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
Secondary identifying numbers	N/A

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

Study design	Randomized double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The effect of vitamin A and zinc supplementation on the bacteriological response of persons with pulmonary tuberculosis in the Western Cape
Study objectives	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(s)	Research and Ethics Committee at the University of Cape Town, 08/03/2005, ref: REC 137/2003
Health condition(s) or problem(s) studied	Pulmonary tuberculosis
Intervention	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.
Intervention type	Supplement
Primary outcome measure	Sputum smear and culture conversion rates, measured every week up to 8 weeks.
Secondary outcome measures	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)
Overall study start date	01/04/2005
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	182
Key inclusion criteria	Patients with newly diagnosed smear-positive pulmonary tuberculosis attending community health care centres in Delft, Cape Town.
Key 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
Date of first enrolment	01/04/2005
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

South Africa

Study participating centre

PO Box 6614

Cape Town
7538
South Africa

Sponsor information

University of the Western Cape, School of Public Health, Division of Dietetics (South Africa)
University/education

Division of Dietetics
School of Public Health
University of the Western Cape
Private Bag X17
Bellville
Cape Town
7535
South Africa

"ROR"	https://ror.org/00h2vm590

Funders

Funder type

Not defined

National Research Foundation, South Africa Institutional Research Development (grant number: 2067444)

No information available

The Norwegian Programme for Development, Research and Higher Education Network (grant number: NUFUPRO-2007/10183)

No information available

South African Sugar Association Nutrition Research (grant number: 200)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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