Pulmonary tuberculosis Infections and Infestations Pulmonary tuberculosis
Conditions
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 (
Sponsors
University of the Western Cape, School of Public Health, Division of Dietetics (South Africa)
Eligibility
Inclusion criteria
Inclusion criteria: Patients with newly diagnosed smear-positive pulmonary tuberculosis attending community health care centres in Delft, Cape Town.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum smear and culture conversion rates, measured every week up to 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
South Africa
Outcome results
None listed