The effect of vitamin A and zinc supplementation on the bacteriological response of persons with pulmonary tuberculosis in the Western Cape

ISRCTN ISRCTN80852505
DOI https://doi.org/10.1186/ISRCTN80852505
Protocol serial number N/A
Sponsor University of the Western Cape, School of Public Health, Division of Dietetics (South Africa)
Funders National Research Foundation, South Africa Institutional Research Development (grant number: 2067444), The Norwegian Programme for Development, Research and Higher Education Network (grant number: NUFUPRO-2007/10183), South African Sugar Association Nutrition Research (grant number: 200)
Submission date
27/04/2007
Registration date
13/08/2007
Last edited
01/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Marianne Emilie Visser
Scientific

PO Box 6614
Welgemoed
Cape Town
7538
South Africa

Study information

Primary study designInterventional
Study designRandomized double-blind placebo-controlled trial
Secondary study designRandomised controlled trial
Scientific titleThe effect of vitamin A and zinc supplementation on the bacteriological response of persons with pulmonary tuberculosis in the Western Cape
Study objectivesTo 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(s)Research and Ethics Committee at the University of Cape Town, 08/03/2005, ref: REC 137/2003
Health condition(s) or problem(s) studiedPulmonary tuberculosis
InterventionPatients 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.
Intervention typeSupplement
Primary outcome measure(s)

Sputum smear and culture conversion rates, measured every week up to 8 weeks.

Key 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)

Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration182
Key inclusion criteriaPatients with newly diagnosed smear-positive pulmonary tuberculosis attending community health care centres in Delft, Cape Town.
Key exclusion criteria1. 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
Date of first enrolment01/04/2005
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • South Africa

Study participating centre

PO Box 6614
Cape Town
7538
South Africa

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2011 Yes No
Results article results 01/01/2015 Yes No
BMC - Part of Springer Nature Springer Nature