PDF of Trial

CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Thu, 18 May 2023 14:59:00 GMT)

CTRI Number CTRI/2010/091/006112 [Registered on: 27/12/2010] -

Last Modified On 13/02/2013
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Other (Specify) [Food supplement]
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Randomized trial of diet supplementation in HIV and tuberculosis
Scientific Title of Randomized trial of diet supplementation in HIV and tuberculosis
Study
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Thambu David Sudarsanam
Trial Coordinator
(multi-center study) Designation
Affiliation
Address Department of Medicine Unit 2 Christian Medical College
Vellore
TAMIL NADU
632004
India
Phone 04162282052
Fax
Email thambu@cmcvellore.ac.in
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Gagandeep Kang
Query)
Designation
Affiliation
Address Dept. of GI Sciences Christian Medical College
Vellore
TAMIL NADU
632004
India
Phone 9894070266
Fax
Email gkang@cmcvellore.ac.in
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Gagandeep Kang
Designation
Affiliation
Address Dept. of GI Sciences Christian Medical College
Vellore
TAMIL NADU
632004
India
Phone 9894070266
Fax
Email gkang@cmcvellore.ac.in

page 1 / 3
 PDF of Trial
CTRI Website URL - http://ctri.nic.in

Source of Monetary or Source of Monetary or Material Support

Material Support
> Fogarty International Center
Primary Sponsor Primary Sponsor Details
Name Christian Medical College
Address Vellore TN 632004
Type of Sponsor Private medical college
Details of Secondary Name Address
Sponsor
Christian Medical College Vellore TN 632004
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Thambu David Dept. of Medicine Christian Medical 04162282052
Sudarsanam College,-632004
Vellore thambu@cmcvellore.ac
TAMIL NADU .in
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Christian Medical Approved 08/10/2004 Yes
College Institutional
Review Board
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Malnutrition in tuberculosis and HIV
Intervention / Type Name Details
Comparator Agent
Intervention Dietary Supplement 70 g supplement three times a
day for 6 months
Comparator Agent Dietary counselling Counselling at initiation of
anti-tuberculous therapy
Inclusion Criteria Inclusion Criteria
Age From 12.00 Year(s)
Age To 75.00 Year(s)
Gender Both
Details Newly diagnosed tuberculosis patients >12 years<br/> Either sputum
positive for acid fast bacilli or sputum negative but with clinical and
radiological evidence of pulmonary tuberculosis or culture and/or
biopsy proven extra pulmonary tuberculosis
Exclusion Criteria Exclusion Criteria
Details Relapsed tuberculosis End stage renal or liver disease CD4 counts
>200 (among the HIV positive) Body mass index (BMI) >19 Not from
Vellore district Not willing to give written informed consent to
participate
Method of Generating Computer generated randomization
Random Sequence
Method of Alternation
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome Timepoints

page 2 / 3
 PDF of Trial
CTRI Website URL - http://ctri.nic.in

Good outcome of tuberculosis treatment under Evaluated at end of directly observed short
the Revised national Tuberculosis Control course chemotherapy, six months
Programme (cure or completion of treatment
classified as good outcomes)
Secondary Outcome Outcome Timepoints
Body composition, compliance with intervention At 1, 2, 4 and 6 months
and therapy, quality of life
Target Sample Size Total Sample Size=100
Sample Size from India=100
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=
Phase of Trial Phase 2
Date of First 12/01/2005
Enrollment (India)
Date of First 12/01/2005
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0
Recruitment Status of Completed
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Trop Med Int Health. 2011;16:699-706. Pilot randomized trial of nutritional supplementation in
patients with tuberculosis and HIV-tuberculosis coinfection receiving directly observed short-course
chemotherapy for tuberculosis. Sudarsanam TD, John J, Kang G, Mahendri V, Gerrior J, Franciosa
M, Gopal S, John KR, Wanke CA, Muliyil J.
Brief Summary This pilot study was conducted to investigate the effects of nutritional supplementation on the
outcome and nutritional status in south Indian patients with tuberculosis (TB) patients with and
without and TB-human immunodeficiency virus (HIV) co-infection on anti-tuberculous therapy. A
pilot randomized controlled trial on the effect of a locally prepared cereal-lentil mixture providing 930
Kcal macro- and a multi-vitamin micronutrient supplementation during anti-tuberculous therapy was
conducted in 81 newly diagnosed TB alone and 22 TB-HIV co-infected patients, among whom 51
received and 52 did not receive the supplement. The primary outcome evaluated at completion of
TB therapy was outcome of TB treatment. Secondary outcomes included body composition,
compliance and condition on follow up one year after cessation of TB therapy and supplementation.
There was no significant difference in TB outcomes at the end of treatment, but HIV-TB co-infected
individuals had four times greater odds of poor outcome than those with TB alone. Among TB
patients, 1/37 (2.7%) supplemented and 5/41(12.2%) of those not supplemented had poor
outcomes, while among TB-HIV co-infected individuals, 3/13 (23.1%) supplemented and 3/8
(37.5%) non-supplemented patients had poor outcomes at end of treatment and the differences
were more marked after one year of follow-up. Although there was a clear trend of benefit for both
TB alone and TB-HIV coinfection, the results were not statistically significant at the end of TB
treatment, possibly because of limited sample size.

page 3 / 3

Powered by TCPDF (www.tcpdf.org)