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

Not Applicable

Completed

Conditions: Pulmonary tuberculosis
Infections and Infestations

Registration Number: ISRCTN80852505

Lead Sponsor: niversity of the Western Cape, School of Public Health, Division of Dietetics (South Africa)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 182

Inclusion Criteria

Patients with newly diagnosed smear-positive pulmonary tuberculosis attending community health care centres in Delft, Cape Town.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sputum smear and culture conversion rates, measured every week up to 8 weeks. <br>

Secondary Outcome Measures

Name	Time	Method
The following will be assessed at baseline, 2 and 8 weeks: <br>1. Radiologic resolution <br>2. Anthropometrical status (body mass index, arm muscle circumference, percentage body fat) <br>3. Serum micronutrient levels (retinol, zinc, iron and copper) <br>4. Performance status (Karnofsky scale) <br>5. Immunological parameters (Interferon-gamma)