THESIS PROTOCOL

Thesis Title

Measurement of blood chromium and biomarker of

oxidative stress and their correlation with pulmonary
functions in tannery workers of Bangladesh

Principal investigator
Dr. Masood Salehin
M. Phil student (Medical Science) Physiology,
Final part
Department of Physiology
Dhaka Medical College, Dhaka.
Session: 2014-2015
To
The Chairman,
Ethical Review Committee,
Dhaka Medical College, Dhaka.

Subject: Approval of thesis protocol by the Research Review Committee (RRC).

Dear Sir,

I would like to inform you that Departmental R.R.C is completed. Now the thesis
protocol is sent for evaluation by ethical review committee.

Name and Course Title

Dr. Masood Salehin Measurement of blood chromium and

M.Phil Physiology
biomarker of oxidative stress and their
Final Part
correlation with pulmonary functions in
tannery workers of Bangladesh.

With thanks,

Prof. Qazi Shamima Akhter

Head, Department of Physiology,
Dhaka Medical College, Dhaka.

2
To
Professor Qazi Shamima Akhter,
Head, Department of Physiology,
Dhaka Medical College,
Dhaka.

Subject: Application for approval of thesis protocol.

Title: Measurement of blood chromium and biomarker of oxidative stress

and their correlation with pulmonary functions in tannery workers of
Bangladesh.

Sir,

With due respect, I would like to submit my protocol as a student of M. Phil

(Medical Science) final part Physiology, Dhaka Medical College. I humbly request
you to kindly approve my protocol for thesis work.

I, therefore, pray and hope that, you would be kind enough to approve my protocol
and allow me to work in your department to complete the thesis in due time.

Your most obedient student.

Dr. Masood Salehin

M. Phil student (Medical Science), Physiology
Final Part
Department of Physiology
Dhaka Medical College, Dhaka.

3
To
The Principal,
Dhaka Medical College,
Dhaka.

Subject: Application for approval of budget for thesis work.

Title: Measurement of blood chromium and biomarker of oxidative stress

and their correlation with pulmonary functions in tannery workers of
Bangladesh.

Sir,

With due respect, I beg to state that I am a student of M. Phil (Medical Science)
final part Physiology, Department of Physiology, Dhaka Medical College. I have
selected the topic mentioned above for my thesis work.

Professor Dr. Qazi Shamima Akhter, Head of the Department of Physiology,

Dhaka Medical College, Dhaka has given her kind consent to guide my thesis
work.

I, therefore, pray and hope that, you would be kind enough to approve a budget for
my thesis work and oblige thereby.

Obediently yours,

Dr. Masood Salehin

M. Phil student (Medical Science), Final part
Department of Physiology
Dhaka Medical College, Dhaka.

4
To
The Chairman
Ethical Review Committee
Dhaka Medical College, Dhaka

Subject: Application for ethical clearance of thesis protocol.

Sir,

With due respect, I beg to state that I am a student of M. Phil (Medical Science)
final part Physiology, Department of Physiology, Dhaka Medical College. I would
like to submit my thesis work in partial fulfillment of the degree of Master of
Philosophy (M. Phil) in Medical science.

The title of my thesis is Measurement of blood chromium and biomarker of

oxidative stress and their correlation with pulmonary functions in tannery
workers of Bangladesh.

Professor Dr. Qazi Shamima Akhter, Head of the Department, Physiology, Dhaka
Medical College, Dhaka has given kind consent to guide my thesis work.

I, therefore, pray and hope that, you would be kind enough to grant ethical
clearance of my protocol and oblige thereby.

With regards,

Dr. Masood Salehin

M. Phil student (Medical Science), Physiology
Final part
Department of Physiology
Dhaka Medical College, Dhaka.

5
To
The Dean,
Faculty of Post Graduate Medicine,
Dhaka University,
Dhaka.

Subject: Application for forwarding of the thesis protocol.

Title: Measurement of blood chromium and biomarker of oxidative stress

and their correlation with pulmonary functions in tannery workers of
Bangladesh.

Sir,

With due respect, I beg to state that I am a student of M. Phil (Medical science)
final part Physiology, Department of Physiology, Dhaka Medical College. I have
selected the topic mentioned above for my thesis work. Now I humbly request your
permission to submit this protocol.

Professor Dr. Qazi Shamima Akhter, Head of the Department, Physiology, Dhaka
Medical College, Dhaka has given kind consent to guide my thesis work.

I, therefore, pray and hope that, you would be kind enough to forward my protocol
and oblige thereby.

Obediently yours,

Dr. Masood Salehin

M. Phil student (Medical Science), Physiology
Final part
Department of Physiology
Dhaka Medical College, Dhaka.

6
 PART A

THESIS PROTOCOL

1. Project Title : Measurement of blood chromium and

biomarker of oxidative stress and their
correlation with pulmonary functions in tannery
workers of Bangladesh.

2. Principal Investigator : Dr. Masood Salehin

M. Phil student (Medical Science), Physiology
Final part
Department of Physiology
Dhaka Medical College, Dhaka.

3. Guide : Prof. Dr. Qazi Shamima Akhter

Head, Department of Physiology,
Dhaka Medical College, Dhaka.

4. Place of Study : Department of Physiology

Dhaka Medical College, Dhaka.

5. Type of Study : Cross-sectional study

6. Duration of study : One calendar year

(July 2015 to June 2016)

7. Date of
Commencement : 01-07-2015

8. Date of Completion : 30-06-2016

7
9. Date of submission : June 2016

10. Total cost : Approximate Tk. 1,80,000.00

11. Cost provided by : Principal investigator

12. Purpose of Protocol : This protocol will be submitted in partial

fulfillment for the degree of Master of Philosophy
in Medical Physiology and contribute to the
subject.

13. Involvement of : Department of Physiology, Dhaka Medical College.

Department Department of Food and Nutrition, Dhaka
University.
Bangladesh Atomic Energy Commission, Dhaka

14. Signature of Principal :

Investigator

Dr. Masood Salehin

M. Phil student (Medical Science), Physiology
Final part
Department of Physiology
Dhaka Medical College, Dhaka.

16. Endorsement of the :

head of the department

Prof. Dr. Qazi Shamima Akhter

Designation: Professor and Head,
Department of Physiology,
Dhaka Medical College, Dhaka.

8
 PART B

Principal investigators information sheet

Name : Dr. Masood Salehin

Present Position : M. Phil student (Medical Science)

Physiology, Final part
Department of Physiology
Dhaka Medical College, Dhaka.

Resident Address : 91/F, Azimpur Officers Quarters, Dhaka.

Academic Background : MBBS.

Rangpur Medical College, Rangpur.

Signature of
Principal Investigator:

Dr. Masood Salehin

M. Phil student (Medical Science), Physiology
Final part
Department of Physiology
Dhaka Medical College, Dhaka.

9
 Title

Measurement of blood chromium and biomarker of

oxidative stress and their correlation with pulmonary
functions in tannery workers of Bangladesh

10
 PART - C

Project title: Measurement of blood chromium and biomarker of oxidative stress

and their correlation with pulmonary functions in tannery workers of Bangladesh.

Abstract:

Background: Tannery workers are exposed to many chemical compounds during

their daily work activities. Among them, chromium is the most harmful element.
Deterioration of pulmonary functions is one of the major hazards of chromium
exposure. It also induces oxidative stress. So, there is a higher risk of developing
acute and chronic respiratory diseases in tannery workers as they are exposed to
chromium for prolonged period.

Objective: The present study will be carried out to assess blood chromium and
biomarker of oxidative stress levels and their correlation with pulmonary functions
in tannery workers of Dhaka city.

Method: A cross-sectional study will be conducted in the Department of

Physiology of Dhaka Medical College, Dhaka from July 2015 to June 2016. A total
of 70 subjects will be selected with the age ranging from 20 to 45 years. Among
them, 35 tannery workers will be considered as the study group and 35 age and
BMI matched healthy adult males will be considered as control group for
comparison. The subjects will be selected from different tanneries in Hazaribagh at
Dhaka city and through personal contact on the basis of exclusion and inclusion

11
criteria. The study parameters will include blood chromium, which will be
estimated in the laboratory of the Bangladesh Atomic Energy Commission, Dhaka;
plasma malondialdehyde, which will be estimated in the Institute of Nutrition and
Food Science, University of Dhaka; and pulmonary function test (FVC, FEV 1,
FEV1/FVC, PEFR), will be estimated in the Department of Physiology of Dhaka
Medical College. Data will be collected in pre-designed structured questionnaire
form by the researcher himself. The data will be analyzed by computer based
statistical software SPSS (Statistical Package for Social Sciences) Version 20.

Result: Result will be presented as mean and standard deviation (mean SD).
Comparison between two groups will be done by unpaired Students t test and
associations between variables will be measured by Chi Square test accordingly,
where applicable P value of <0.05 will be considered as significant.

Discussion: On the basis of the results discussion will be made.

Conclusion: On the basis of result & discussion, conclusion will be made.

12
 PART - D

Introduction

According to World Health Organization, an occupational disease is any disease

contracted primarily as a result of an exposure to risk factors arising from work
activity (WHO 2016). The ILO (International Labor Organization) list of
occupational diseases divides them into four broad categories. Firstly, occupational
diseases caused by exposure to agents (chemical agents, physical agents and
biological agents and infectious or parasitic diseases) arising from work activities.
Secondly, ILO divided occupational diseases by target organ systems which
include respiratory diseases (e.g. COPD), skin diseases (e.g. contact dermatoses),
musculoskeletal disorders (e.g. tenosynovitis) and mental and behavioral disorders
(e.g. post-traumatic stress disorder). Thirdly, occupational cancer (e.g. cancer
caused by chromium VI compounds) and fourthly, other diseases (e.g. miners
nystagmus) (ILO 2010).

There is an estimated death of about 2.02 million people in each year from work-
related diseases. Of the estimated 6,300 work-related deaths that occur every day,
5,500 are caused by various types of work-related diseases. The ILO estimates that
160 million cases of non-fatal work related diseases occur annually (ILO 2013).

According to the Labour Force Survey (2007) that was carried out in 27 EU
countries, 8.6% of the respondents with age ranging from 15 to 64 years had work
related health problem in the past 12 months.

13
The lungs are much prone to be exposed to environmental pollutants because of
having direct contact with the inspired air, large surface area, high vascularity and
thin alveolar epithelium. Various pulmonary diseases may occur as a result of
repeated, long-term exposure to irritant or toxic substances in the working place
(Chandrasekaran et al. 2014).

Occupational lung diseases constitute a major part among all the occupational
diseases. Epidemiological studies in developing countries show that about 30% to
50% workers of primary industries and high-risk sectors may suffer from silicosis,
pneumoconiosis and other lung diseases (Fedotov & Eijkemans 2007).

A study was performed to observe the prevalence of occupational diseases of

leather tannery workers by Mohanta et al. ( 2012) among 4000 people working in
35 tannery industries at Hazaribagh, Dhaka. They revealed that most of the
workers were suffering from different diseases. About 35% of the tannery workers
were suffering from gastrointestinal disease, 25% from dermatological disease, and
10% from headache, hypertension and lethargy.

Leather tanning is a process by which decomposable animal skin is converted into

non-decomposable leather (Varsha & Apurba 2008). As part of this process,
dermal collagen fibers are stabilized by means of chemical treatment after removal
of the epidermis and subcutaneous tissue (Issever et al. 2007). It is important for
converting hides and skins into usable materials for production of leather based
consumer products.

According to the Oxford Dictionary, a tannery is a place where animal hides are
tanned by a tanner. Tannery industry is a long-established one in our country. It
contributes in the development of our national economy by earning a great deal of

14
foreign currency, which is about 1900 crore in every year. At present, there are
about 65,000 manpower engaged in this industry. There are about 220 big, medium
and small tanneries in our country, of which 194 are situated at Hazaribag in
Dhaka (Muhammad & Haque 2012).

According to the Environmental Protection Agency (EPA), the most common

tanning agents used are trivalent chromium and vegetable tannins (extracted from
specific tree barks). Other tanning agents are alum, syntans, formaldehyde,
glutaraldehyde and heavy oils. The Emergency Planning and Community Right-
To-Know Act (EPCRA), section 13, reported a list of chemicals used for leather
tanning which includes ammonia, butyl alcohol, chromium, chromium compounds,
ethylbenzene, formaldehyde, hydrochloric acid, manganese, methanol, nitrate
compounds, sulfuric acid, toluene, zinc compounds etc. among other chemicals
(EPA April 2000). Some of these chemicals are also used for leather finishing.

Chromium is a hard metal used in various industries. The most important stable
states of chromium are elemental, trivalent and hexavalent forms. Naturally,
chromium is present as trivalent; and both trivalent (Cr III) and hexavalent (Cr VI)
chromium compounds are biologically important (Dayan & Paine 2001).

Chromium was first determined to be essential for animals by Schwartz and Mertz
in 1963 (Ahsan et. al 2006). It is thought to potentiate the action of insulin by
facilitating insulin-receptor binding at cell surfaces. Thus it enhances insulin
sensitivity and responsiveness in peripheral tissues and reverses the effects of
clinical hyperglycemia (Mooradin & Morley 1987). Chromium (III) in low doses is
an essential dietary mineral for the body. Studies in man and experimental animals
have established the essential role of trace amounts of Cr (III) (50-200g/day) for

15
the maintenance of normal glucose metabolism (WHO Environmental Health
Criteria 61).

On the other hand, elevated amounts of chromium may be hazardous. Dose,

exposure duration, and the specific compound involved can determine chromiums
adverse health effects. Chromium (VI) is generally more toxic than Cr (III).
Exposure to chromium is possible through inhalation, ingestion and dermal routes
(ATSDR CSEM Dec 18 2008).

Several toxic effects are associated with exposure to chromium compounds. The
respiratory tract is the main target organ of Cr (VI) toxicity associated with both
acute and chronic inhalation (ATSDR Sep 2012). Acute exposure may cause
shortness of breath, coughing and wheezing (Sobaszek et al. 2000). Chronic
exposure leads to ulcerations and perforations of the nasal septum, chronic
bronchitis, decreased pulmonary function, pneumonia and other respiratory effects
(Bradshaw et al. 1998).
Occupational exposures often include mixed exposure to both Cr (III) and Cr (VI)
[EPA 1998]. Cr (VI) has been accepted as the principal cause of toxic effects
including certain cancers and Cr (III) is regarded as an irritant to the respiratory
tract. Pulmonary irritant effects following inhalation of chromium dust can include
asthma, chronic bronchitis, chronic pharyngitis, chronic rhinitis, polyps of the
upper respiratory tract, tracheobronchitis and ulceration of the nasal mucosa with
possible septal perforation ( Dayan & Paine 2001; Linberg & Hedenstierna 1983).
Occupational exposure to Cr (VI) compounds in a number of industries has been
associated with increased risk of respiratory system cancers [ATSDR 2000]. On
the basis of experimental and epidemiologic evidence, the International Agency for
Research on Cancer (IARC) has classified Chromium VI as a group 1 carcinogen
(recognized human carcinogen).

16
Chromium is one of the most harmful chemicals used in tannery industries. Most
leather is chrome-tanned; nearly 90% of all leather produced is tanned using
chromium salts (Stein and Schwedt). Generally 8% of the basic chromium sulphate
salt is used for conventional tanning. It binds with the collagenous protein to
convert to leather (Afify et. al 2013). There is growing concern over dangerous and
harmful aspects of chemicals used in the leather tannery industry.

The mechanism of Cr (VI) cytotoxicity is not completely understood, but several

studies have shown that Cr (VI) compounds induce oxidative stress, DNA damage,
apoptotic cell death and altered gene expression (Bagchi et al. 2002; Wise et al.
2002). The reduction of Cr (VI) generates intermediate unstable states, such as Cr
(V) or Cr (IV), that may mediate the formulation of several free radicals e.g.
hydroxyl, thiyl, ascorbate and carbon-based radicals that are capable of damaging
macromolecular targets, such as DNA ( Ding & Shi 2002; Levina & Lay 2005).

Oxidative stress induces peroxidation of membrane lipids which amplifies cellular

damage. It generates a variety of relatively stable products like MDA
(Malondialdehyde) which is a physiological ketoaldehyde and acts as a marker for
oxidative stress (Waseem et al., 2012). In Egypt, a study was carried out among
workers having potentially high exposure to chromium in the leather tanning
industry. On that study, the blood and urinary chromium and plasma
malondialdehyde levels of the tannery workers were significantly higher than
control group (Elhosary et al., 2014).

The pulmonary function tests have paved way towards scientific approach in
diagnosis, prognosis and management of respiratory disorders by the early
recognition of their decline in industrial workers. Pulmonary function can be
assessed by computerized spirometer. The spirometer measures all the parameters

17
of the pulmonary function tests like FEV1 (Forced expiratory volume in the first
second), FVC (Forced vital capacity), PEFR (Peak expiratory flow rate),
FEV1/FVC and gives an idea about the lung condition (Pal et al., 2010).Thus by
performing pulmonary functions among leather tannery workers, we can bring to
limelight, the effect of chromium and leather dust on lung functions.

From the above discussion, we find that exposure to chromium compounds is a

major cause of development of respiratory disorders among the tannery workers.
Different researchers and organizations of different countries have performed study
on pulmonary function tests of tannery workers and emphasized the impact of
chromium exposure on them. However, in Bangladesh, few studies have been done
on pulmonary function tests, blood chromium, or plasma malondialdehyde levels
among different professionals who are exposed to chromium exposure for long
periods. As there is less research work done in our country regarding this topic,
measurement of blood chromium and plasma malondialdehyde and their
correlation with pulmonary functions in tannery workers of Bangladesh is not
precisely known. This study may help create awareness among the tannery workers
and the authority in Bangladesh regarding the complications of chromium
exposure.

18
 Rationale

The contribution of the tannery industry to the economy of Bangladesh is

remarkable. In May 2014, the leather sector of the country crossed the $ 1 billion
mark in annual exports for the first time (The Asia Foundation 2015). The working
population in the tanneries is very much prone to develop various types of health
hazards. Some of the common illnesses are respiratory disorders, skin diseases,
ocular illness, musculo-skeletal problems etc. Among these, the respiratory
diseases constitute a major part. These may occur due to direct or indirect contact
with various chemicals used in the tannery industries, among which chromium is
the most toxic element. The exposure to chromium can cause various types of
respiratory pathology e.g. chronic bronchitis, bronchial asthma, pulmonary
fibrosis, inflammation and ulceration of the mucous membranes of the mouth and
pharynx (Baruthio 1991).

Therefore, it is obvious that there is a need to improve the health status of the
workers in the tannery industries. In order to do that, it is necessary to identify the
factors influencing the health status of the tannery workers. Different researchers
and organizations of different countries have performed study on pulmonary
function tests of tannery workers and emphasized the impact of chromium
exposure on them. However, in Bangladesh, few studies have been done on this
topic. On the basis of this background, the present study is designed to evaluate the
effects of chromium toxicity on pulmonary functions among the tannery workers
of Bangladesh. This study will help to provide information and create awareness
among the tannery workers and their authority regarding the complications of
chromium exposure so that they can provide necessary protective measures.

19
 Research Question

Do pulmonary functions decrease and blood chromium and biomarkers of

oxidative stress increase in tannery workers of Bangladesh?

20
 Hypothesis

Pulmonary functions decrease and blood chromium and biomarkers of oxidative

stress increase in tannery workers of Bangladesh.

21
 Objectives

General Objective

To assess blood chromium and biomarker of oxidative stress levels and their
correlation with pulmonary functions in tannery workers of Bangladesh.

Specific Objectives

1. To estimate blood chromium level of tannery workers in study group.

2. To estimate plasma malondialdehyde level to assess the oxidative stress of
tannery workers in the study group.
3. To estimate PEFR, FVC and FEV1 & calculate FEV1: FVC to measure the
pulmonary functions of tannery workers in study group.
4. To estimate all the above mentioned parameters in age and BMI matched
healthy individuals in control group for comparison.
5. To observe the relationship among pulmonary functions, blood chromium
and plasma malondialdehyde levels of tannery workers in study group.

22
 Methods

Study design

Cross sectional study.

Study place

Department of Physiology, Dhaka Medical College, Dhaka.

Study period

From July 2015 to June 2016.

Ethical issue

Ethical permission will be taken from Ethical Review Committee of Dhaka

Medical College, Dhaka.

Sample size

A total number of 70 adult subjects with the age ranging from 20 to 45 years will
be included in this study.

Study population

A total number of forty (35) tannery workers will be included in study group and
will be selected from different tanneries of Dhaka city. Age matched forty (35)
healthy subjects serving in different offices in Dhaka city will be considered as
control group for comparison.

Grouping of the subjects: Sample size will be divided into two groups:

Group A (Control group): Consisted of 35 subjects.

Group B (Study group): Consisted of 35 tannery workers.

23
Selection criteria of subjects

Selection criteria:

Inclusion criteria:

For study group:

1. Tannery workers .
2. Age between 20 to 45 years.
3. Serving for at least 5 years in tannery industry.
For control group:

1. Age & BMI matched healthy adult males.

Exclusion criteria:

For both groups:

1. Age < 20 years and >45 years old patients.

2. Serving < 5 years in the tannery industry.
3. History of chronic obstructive pulmonary disease (COPD), asthma,
musculoskeletal abnormality, anemia, diabetes mellitus, heart disease, liver
disease, kidney disease, TB, malignancy.
4. Smokers.
5. History of regular alcohol consumption.
6. History of regular chewing tobacco consumption.
7. History of taking drugs, such as bronchodilators, steroids, antihypertensive,
anti diabetic.
Data collection

A structured data collection sheet is designed and prepared. Data will be collected
by the principal investigator. A structured data collection sheet is attached
herewith.

24
Facilities

Facilities available are subjects, resources and equipments.

Principles of procedure of measurement of study parameters:

After selection of the subjects, the nature, purpose and benefit of the study will be
explained to each subject in details. They will be encouraged for voluntary
participation. They will be allowed to withdraw from the study whenever they like.
Informed written consent will be taken from the participants. Before performing
pulmonary function and taking blood, detailed family and medical history will be
taken. Blood pressure will be measured. All the informations will be recorded in a
prefixed questionnaire. After proper washing of the mouth piece of the spirometer
pulmonary function test will be done with proper care. Pulmonary function tests
will be done by using computerized spirometer in the sitting position with nose
clip. After demonstrating the required manure in group, test results were noted
after performing acceptable technique 3 times and the highest value was taken.
With aseptic precaution, 5 ml of venous blood will be collected from ante-cubital
vein by a disposable plastic syringe from each subject for estimation of
biochemical tests. Blood Chromium (Cr) levels will be estimated in the laboratory
of the Atomic Energy Commission, Dhaka by automated biochemistry analyzer
machine. Plasma malondialdehyde (MDA) will be estimated in the laboratory of
the Institute of Nutrition and Food Science, University of Dhaka by
spectrophotometry.

Result

Results will be recorded in a result sheet.

25
Data analysis

Analysis will be performed by using a computer based statistical program SPSS

(Statistical Package for Social Sciences) Version 20. Result will be presented as
mean and standard deviation (mean SD). Comparison between two groups will
be done by unpaired Students t test and associations between variables will be
measured by Chi Square test accordingly, where applicable P value of <0.05 will
be considered as significant.

Discussion

Discussion will be made after result analysis with references.

Conclusion

Conclusion will be drawn on the basis of results and discussion.

26
 Budget

Total budget: 1,80,000.00 ( One lac eighty thousand taka only)

Detailed budget:

Budget List Cost

Sample Cost 1,00,000.00
Personnel /Professional Scientific Staff Cost 10,000.00
Supplies and Materials 20,000.00
Travel Cost 20,000.00
Office Stationary 5,000.00
Data Analysis 10,000.00
Printing and Binding 5,000.00
Miscellaneous 10,000.00
Total Budget 1,80,000.00

Milestone of the thesis work

Sl. No. Milestone Time Duration

1 Literature survey and topic 2 months 01-07-15 to 31-08-15
selection
2 Protocol Writing 2 months 01-09-15 to 31-10-15
3 Data collection and thesis writing 3 months 01-11-15 to 31-01-16
4 Data analysis and writing 2 months 01-02-16 to 31-03-16
5 Correction of thesis 2 months 01-04-16 to 31-05-16
6 Printing and binding 1 month 01-06-16 to 30-06-16

27
 DATA COLLECTION FORM
ID No. :
Name:...
Age:Sex:..
Fathers/Husbands name:.......................................
Address:...
Telephone No..
Variable Level
Height (Meter)
Weight (Kg)
BMI
FVC
FEV1
FEV1 : FVC
PEFR
Blood chromium level
Plasma malondialdehyde level
Education 1. No formal education
2. Primary
3. SSC
4. HSC
5. Graduate
6. Post graduate
Profession 1. Tannery worker
2. Student
3. Other
Socio-economic condition 1. Upper class
2. Middle class
3. Lower class
BP:
a. Systolic
b. Diastolic

28
 MelYv cK Ask bqvi mwZc

Melbv wkivbvg : Measurement of blood chromium and biomarker of oxidative

stress and their correlation with pulmonary functions in tannery workers of
Bangladesh

MelKi bvg: Wvt gvmy` mvjnxb

ZveavqKi bvg: AavcK Wv: KvRx kvgxgv Avvi

wefvMxq cavb, wdwRIjwR wefvM, XvKv gwWKj KjR, XvKv

cwZvbi bvg: wdwRIjwR wefvM, XvKv gwWKj KjR, XvKv|

MelYv weeiYx: h mg kwgK Uvbvix wk KvR Kib, Zviv cwZwbqZ

Kgj eeZ wewfb cKvi wZKi ivmvqwbK c`v_i msk welwqvq
Avv nb| Zviv dzmdzmi mgmvq fzMb | Zv`i i Chromium Gi gvv
^vfvweKi Zzjbvq ew cZ cvi Ges Pulmonary Function ^vfvweKi Zzjbvq
Kg hZ cvi| dj Zv`i dzmdzmi SuywK evoZ cvi| Gi dj dzmdzmRwbZ
gZzi SuywKI eo hZ cvi| GQvov, Oxidative Stress-Gi Rb Zv`i i wKQz
Biomarker ew cvq| ZvB Uvbvix kwgK`i Pulmonary Function test, Blood
Chromium I Plasma Malondialdehyde Gi gvv wbYq Ki Gi cwZKvi I
cwZiva Kivi eev bqvi j GB MelYvwU Kiv nQ|

GB MelYv KvRi Rb Avcbvi nvZ _K 5 wgwg. i m~Y wbivc` I

SuywKgy Dcvq msMn Kiv ne| ZvZ mvgvb ev_v Abyfe nZ cvi, wK
Kvb ^v SuywKi mvebv bB|

MelYvq AskMnY Kij Kvbic kvixwiK ev gvbwmK ^vi AebwZ ne bv

Ges Avcbvi mKj Z_ I MvcbxqZv iv Kiv ne| Avcwb hKvbv gyn~Z
MelYv cK nZ Avcbvi bvg cZvnvi KiZ cvieb|

GB MelYvi dj ivM wbYq I wPwKrmvi mvdj ew Kie|

29
MelYvq AskMnYKvix:

1) GB mwZc ^vi c`vbi gvag Avwg wbwZ KiwQ h, mwZ c

Avwg wevwiZ cowQ/bwQ I MelYvi welq mKj cki Di
cqwQ|
2) Avwg eySZ ciwQ h, MelYvq AskMnY Kij Avgvi Kvb ^v
SuywKi mvebv bB, eis MelYvi djvdj cieZxZ ^v SuywK KgvZ
mvnvh Kie|
3) Avwg ^Qvq MelYv cK Ask wbZ Ges Avgvi ^v msv
cqvRbxq Z_ MelYv mswk`i c`vb mwZ w`wQ|

AskMnYKvixi bvg:....................................................................

AskMnYKvixi ^vi/

wUcmB:...................................

ZvwiL:....................................

MelKi evLv c`vbKvixi bvg:.................................................................

30
 Reference
Ahsan MM, Shakoori FR, Shakoori AR. Biochemical and haematological
abnormalities in factory workers exposed to hexavalent chromium in tanneries of
Kasur district. Pakistan J Zool. 2006; 38(3): 239-253
Al-muti SA, Ahmad N. Bangladesh: Billion dollar leather sector poised for growth
after environmental reform. [Internet]. Dhaka. The Asia Foundation; 2016 [cited
2016 Mar 28]. Available from:
http://asiafoundation.org/in-asia/2015/04/15/bangladesh-billion-dollar-leather-
sector-poised-for-growth-after-environmental-reform/
ATSDR. Environmental Health and Medicine Education: Case Studies in
Environmental Medicine [Internet]. [Atlanta (GA)]: Agency for Toxic Substances
and Disease Registry; c2008. Chromium Toxicity; 2014 Feb 26 [cited 2016 Mar
24]. Available from:
http://www.atsdr.cdc.gov/csem/chromium/docs/chromium.pdf
ATSDR. Toxic Substances Portal: Toxicological Profile [Internet]. [Atlanta
(GA)]: Agency for Toxic Substances and Disease Registry; c 2012. Toxicological
Profile for Chromium; 2015 Jan 21 [cited 2016 Mar 25]. Available from:
http://www.atsdr.cdc.gov/ToxProfiles/tp7.pdf
Bagchi D, Stohs SJ, Downs BW et al. Cytotoxicity and oxidative mechanisms of
different forms of chromium. Toxicol. 2002; 180(1): 5-22
Baruthio F. Toxic effects of chromium and its compounds. Biol Trace Elem Res.
1992; 32: 145-153
Bradshaw LM, Fishwick D, Slater T et al. Chronic bronchitis, work related
respiratory symptoms and pulmonary function in welders in New Zealand. Occup
Environ Med. 1998; 55: 150-54

31
Chandrasekaran V, Dilara K, Padmavathi R. Pulmonary functions in tannery
workers A cross sectional study. Indian J Physiol Pharmacol 2014; 58(3): 206-
210
Dayan AD, Paine AJ. Mechanisms of chromium toxicity, carcinogenicity and
allergenicity: Review of the literature from 1985 to 2000. Hum and Exp Toxicol.
2001; 20: 439-451
Ding M, Shi X. Molecular mechanisms of Cr(VI)-induced carcinogenesis. Mol
Cell Biochem. 2002; 234/235: 293-300
Elhosary N, Maklad A, Soliman E et al. Evaluation of oxidative stress and DNA
damage in cement and tannery workers in Egypt. Inhal Toxicol. 2014; 26(5): 289-
298
EPA. Emergency planning and community right-to-know act section 313 reporting
guidance for the leather tanning and finishing industry [Internet]. Washington DC:
United States Environmental Protection Agency: c 2000 [cited 2016 Mar 16].
Available from:
https://www.epa.gov/sites/production/files/documents/2000leather.pdf
EPA. Technology Transfer Network: Air Toxics Web Site [Internet]. Washington
DC: United States Environmental Protection Agency: c 1992. Chromium
Compounds; 2000 [cited 2016 Feb 26]. Available from:
https://www3.epa.gov/ttn/atw/hlthef/chromium.html
EPA. Technology Transfer Network: Chapter 9: Food and Agricultural Industries
[Internet]. Washington DC: United States Environmental Protection Agency: c
2016. 9.15 Leather Tanning; 2016 [cited 2016 Feb 23]. Available from:
https://www3.epa.gov/ttn/chief/ap42/ch09/final/c9s15.pdf
Eurostat. Health and safety at work in Europe (1999-2007) [Internet].
Luxembourg: Office for Official Publications of the European Communities; 2010

32
[cited 2016 Mar 15]. Available from:
http://ec.europa.eu/eurostat/en/web/products-statistical-books/-/KS-31-09-290
Fedotov I, Eijkemans G. The ILO/WHO global programme for the elimination of
silicosis. GOHNET Newsl 2007; No. 12
IARC. Preamble to the IARC Monographs [Internet]. [Lyon, France]: International
Agency for Research on Cancer; 2006. IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans; 2015 [cited 2016 Feb 10]. Available from:
http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf
ILO. Occupational Safety and Health: Publications and technical tools [Internet].
Geneva: International Labour Organization: c 2010. ILO List of Occupational
Diseases (revised 2010); 2016 [cited 2016 Mar 10]. Available from:
http://www.ilo.org/safework/info/publications/WCMS_125137/lang--en/index.htm
ILO. Occupational Safety and Health: Publications and technical tools [Internet].
Geneva: International Labour Organization: c 2013. The Prevention of
Occupational Diseases; 2016 [cited 2016 Mar 12]. Available from:
http://www.ilo.org/safework/info/publications/WCMS_208226/lang--en/index.htm
Issever H, Ozdilli K, Ozyildirim BA et al. Respiratory problems in tannery workers
in Istanbul. Indoor and Built Environ. 2007; April
Levina A, Lay PA. Mechanistic studies of relevance to the biological activities of
chromium. Coord Chem Rev. 2005; 249: 281-298
Mohanta MK, Saha AK, Hasan MA. Prevalence and determination of occupational
diseases of leather tannery workers. Univ. J. Zool. Rajshahi Univ. 2012; 31:79-82
Mooradian AD, Morley JE. Micronutrient status in diabetes mellitus. Am J Clin
Nutr. 1987; 45: 877-95
Muhammad N, Haque MA. Physical and mental health of tannery workers and
residential people of Hazaribag area in Dhaka city. ASA Univ Rev.2012; 6(2):
161-169

33
Pal P, Robert J A, Dutta T K et al. Pulmonary Function Test in Traffic Police
Persnnel in Pundicherry. Indian J Physiol Pharmacol 2010; 54(4): 329-336
Sobaszek A, Boulenguez C, Frimat P et al. Acute respiratory effects of exposure to
stainless steel and mild steel welding fumes. J Occup Environ Med. 2000; 42: 923-
931
Varsha M, Apurba D. Biological treatment of tannery waste water for sulfide
removal. Int. J. Chem. Sci. 2008; 6(2): 472-486
Waseem SMA, Hussain MM, Ahmed Z et al. A study of pulmonary functions and
lipid peroxidation biomarker in COPD: Correlation between malondialdehyde and
lung functions. Biomed Res. 2012; 23(1): 66-71
WHO. Programmes: International Programme on Chemical Safety [Internet].
Geneva: World Health Organization: c 2016. Numerical list of EHCs; 2016 [cited
2016 Feb 27]. Available from:
http://www.inchem.org/documents/ehc/ehc/ehc61.htm
WHO. Programmes: Occupational health [Internet]. Geneva: World Health
Organization: c 2016. Occupational and work-related diseases; 2016 [cited 2016
Mar 3]. Available from:
http://www.who.int/occupational_health/activities/occupational_work_diseases/en/

34
 Circle the appropriate answer to each of the following
(If not applicable write NA)

1. Source of Population: 4. Are subjects clearly informed about:

a) Ill subject Yes No a) Nature and purpose of study Yes No
b) Non* ill subject Yes No b) Procedures to be followed including Yes No
c) Minors or persons under c) Physical risks Yes No
guardianship Yes No
d) Invasion of the body Yes No
2. Does the study involve: e) Benefits to be derived Yes No
a) Physical risks to the subject f) Right to refuse, to participate Yes No
Yes No or to withdraw from study.
b) Social risks Yes No h) Confidential handling of data Yes No
c) Psychological risks Yes No i) Compensation Yes No
to subjects
d) Discomfort to subject Yes No Where there are risks or loss of working time or privacy
e) Invasion of the body Yes No Is involved in any particular procedure
f) Invasion of privacy Yes No
g) Disclosure of information 5. Will signed consent form/ verbal consent
Yes No be required:
3. Does the study involve: a) From subject Yes No
a) Use of records Yes No b) From parent or guardian Yes No
(hosp (hospital, medical, death, (if subjects are minors)
birth or others)
b) Use of fetal Yes No 6. Will precautions be taken Yes No
to protect anonymity of subjects
c) Use of organs or body fluid
Yes No

35
Check documents being submitted herewith to committee:

# Umbrella proposal Initially submit an overview (all other requirements

will be submitted with individual studies).

# Protocol (obligatory).

# Abstract summary for Ethical Committee as attachment (Obligatory).

# Informed consent form from parent or guardian

# Verbal consent form for the subject

# Questionnaire or interview schedule.

We agree to obtain approval of the Ethical Review Committee for any

changes involving the rights & welfare of subject or any changes of the
Methodology before making such changes.

Signature of principal investigator

36