|
ISRCTN
|
ISRCTN80852505
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The effect of vitamin A and zinc supplementation on the bacteriological response of persons with pulmonary tuberculosis in the Western Cape
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
To investigate the efficacy of vitamin A and zinc supplementation for 2 months, in conjunction with standard anti-tuberculous therapy, on the bacteriological response of adults with newly diagnosed smear-positive pulmonary tuberculosis.
In South-Africa tuberculosis accounts for more than 80% of all communicable diseases and is regarded as one of the most serious health problems affecting the country. There are an estimated 556 cases per population of 100,000 each year, with the highest incidence in the Western Cape. HIV infection is the greatest individual risk factor for tuberculosis and more than half of smear-positive patients are HIV-infected in South Africa. A recent Indonesian study investigated the combined effect of vitamin A and zinc supplementation to adults with pulmonary tuberculosis. Conversion of positive sputum smears was significantly faster in the micronutrient group than in the placebo group after 2 months of anti-tuberculosis treatment. Earlier sputum conversion is critical in terms of tuberculosis control in South Africa. Our study will therefore aim to determine the efficacy of a low cost micronutrient intervention on short-term outcomes such as bacteriological and immunological responses as well as clinical and nutritional parameters in smear positive adult pulmonary TB patients within the context of co-infection with HIV.
|
|
Ethics approval
|
Research and Ethics Committee at the University of Cape Town, approved on 08/03/2005 (ref: REC 137/2003)
|
|
Study design
|
Randomized, double-blind, placebo-controlled trial.
|
|
Countries of recruitment
|
South Africa
|
|
Disease/condition/study domain
|
Pulmonary tuberculosis
|
|
Participants - inclusion criteria
|
Patients with newly diagnosed smear positive pulmonary tuberculosis attending community health care centres in Delft, Cape Town.
|
|
Participants - exclusion criteria
|
1. Re-treatment patients
2. Patients with extra-pulmonary tuberculosis
3. Patients with Multi-Drug Resistance (MDR) at baseline or during follow-up
4. Patients with elevated alanine transaminase levels (>5 fold increase)
5. Women who are pregnant or wish to become pregnant
6. Women who have given birth within 6 months of study entry
7. Patients with clinical signs of liver disease, renal failure, congestive heart failure or neoplasm 8. Use of corticosteroids
9. Use of supplements containing vitamin A, zinc or iron during the previous month prior to treatment
10. No consent given for a voluntary HIV-test at baseline
|
|
Anticipated start date
|
01/04/2005
|
|
Anticipated end date
|
31/12/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
182
|
|
Interventions
|
Patients will be randomly assigned to the following two groups:
Intervention group: A single dose of 200 000 IU vitamin A (capsule, orally) at study entry plus daily supplementation of 15 mg zinc (tablet, orally) for 2 months
Control group: Placebo capsules (orally) at study entry plus daily placebo tablets (orally) for 2 months.
Both groups will receive standard anti-tuberculosis treatment in addition to the supplement or placebo.
|
|
Primary outcome measure(s)
|
Sputum smear and culture conversion rates, measured every week up to 8 weeks.
|
|
Secondary outcome measure(s)
|
The following will be assessed at baseline, 2 and 8 weeks:
1. Radiologic resolution
2. Anthropometrical status (body mass index, arm muscle circumference, percentage body fat)
3. Serum micronutrient levels (retinol, zinc, iron and copper)
4. Performance status (Karnofsky scale)
5. Immunological parameters (Interferon-gamma)
|
|
Sources of funding
|
1. National Research Foundation, South Africa Institutional Research Development (Grant number: 2067444)
2. The Norwegian Programme for Development, Research and Higher Education Network (Grant number: NUFUPRO-2007/10183)
3. South African Sugar Association Nutrition Research (Grant number: 200)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mrs
Marianne Emilie
Visser
|
|
Address
|
PO Box 6614
Welgemoed
|
|
City/town
|
Cape Town
|
|
Zip/Postcode
|
7538
|
|
Country
|
South Africa
|
|
Sponsor
|
University of the Western Cape, School of Public Health, Division of Dietetics (South Africa)
|
|
Address
|
Division of Dietetics
School of Public Health
University of the Western Cape
Private Bag X17
Bellville
|
|
City/town
|
Cape Town
|
|
Zip/Postcode
|
7535
|
|
Country
|
South Africa
|
|
Date applied
|
27/04/2007
|
|
Last edited
|
13/08/2007
|
|
Date ISRCTN assigned
|
13/08/2007
|
