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To determine if the addition of weekly zinc and weekly zinc plus vitamin A to routine tuberculosis (TB) treatment improves the outcome of the treatment in Nigeria

Diagnosis of tuberculosis and the role of micronutrients in the treatment of pulmonary tuberculosis (PTB) in Nigeria: a double-blinded, placebo-controlled, multicentre, supplementation clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36636609
Enrollment
350
Registered
2009-07-24
Start date
2003-09-01
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Infections and Infestations Respiratory tuberculosis, not confirmed bacteriologically or histologically

Interventions

Patients were randomised in blocks to receive: 1. Anti-TB routine treatment plus 90 mg elementary zinc weekly (as zinc sulphate in a lactose matrix in form of a tablet) plus a placebo

Sponsors

Zankli Medical Centre (Nigeria)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Willingness to take part in the study 2. Newly diagnosed as having active PTB as per the World Health Organization (WHO) definition of smear positive TB 3. Aged 15 years and above, either sex 4. Should not have a history of anti-TB treatment

Exclusion criteria

Exclusion criteria: 1. Moderate to severe surgery during the previous month 2. History of diabetes mellitus or severe cardiovascular, liver or renal diease 3. Previous treatment for TB 4. Taking corticosteroids, zinc or vitamin A supplementation during the previous month 5. Pregnant, lactating or taking oral contraceptives 6. Patient could not attend follow up visits regularly

Design outcomes

Primary

MeasureTime frame
1. To determine the time to sputum clearance of bacilli (proportion of TB bacilli cleared from sputum at enrolment, 2nd and 6th month, using smear microscopy in the three groups) 2. To determine the resolution of lesion areas in chest x-rays in the three groups at enrolment, 2nd and 6th month

Secondary

MeasureTime frame
To look at the clinical and laboratory differences between the three groups at enrolment, 2nd and 6th month.

Countries

Nigeria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026