- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197704
Nutrition, Immunology and Epidemiology of Tuberculosis
November 9, 2010 updated by: Harvard School of Public Health (HSPH)
The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Tuberculosis (TB) remains the single most common infectious disease cause of mortality.
We propose to examine the inter- relationships of nutrition, immunology, and epidemiology with respect to TB in Tanzania.
Given that TB is so much linked with HIV immunologically, clinically, and epidemiologically, it is essential to examine how these relationships are modified by HIV infection.
Published animal and human studies suggest that vitamin deficiency is associated with poor immune response in TB.
By modulating immune function, nutritional supplements may be a useful adjunct to anti-TB drugs, and could lead to the development of shorter drug regimens.
All patients will receive standard anti-TB therapy.
Follow-up visits will occur every two weeks for the first 2 months and monthly thereafter till the end of the study.
Study Type
Interventional
Enrollment (Actual)
876
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Harvard School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women, age 18 to 60 years inclusive
- At least two positive sputum smears for tuberculosis
- Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
- Subjects who grant informed consent to participation
Exclusion Criteria:
- Karnofsky score < 40%
- Hemoglobin < 8.5 g/dl
- Having had treatment for TB exceeding 4 weeks in the last 5 years
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
|
Experimental: Multivitamins
5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium
|
5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection.
Time Frame: Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.
|
Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters.
Time Frame: Rate of change of HIV viral load in HIV positive patients: 2, 5, 8, and 20 months; Absolute change in CD4 counts: 2, 5, 8, and 20 months; Weight change from baseline: 2, 8, and 20 months; Immunological parameters: 2, 8, and 20 months.
|
Rate of change of HIV viral load in HIV positive patients: 2, 5, 8, and 20 months; Absolute change in CD4 counts: 2, 5, 8, and 20 months; Weight change from baseline: 2, 8, and 20 months; Immunological parameters: 2, 8, and 20 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wafaie W Fawzi, MD,DrPh, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Villamor E, Mugusi F, Urassa W, Bosch RJ, Saathoff E, Matsumoto K, Meydani SN, Fawzi WW. A trial of the effect of micronutrient supplementation on treatment outcome, T cell counts, morbidity, and mortality in adults with pulmonary tuberculosis. J Infect Dis. 2008 Jun 1;197(11):1499-505. doi: 10.1086/587846.
- Mehta S, Mugusi FM, Bosch RJ, Aboud S, Urassa W, Villamor E, Fawzi WW. Vitamin D status and TB treatment outcomes in adult patients in Tanzania: a cohort study. BMJ Open. 2013 Nov 18;3(11):e003703. doi: 10.1136/bmjopen-2013-003703.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2000
Primary Completion (Actual)
May 1, 2004
Study Completion (Actual)
May 1, 2004
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
November 11, 2010
Last Update Submitted That Met QC Criteria
November 9, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI45441
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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