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Vitamin A Therapy for Tuberculosis

Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00057434
Enrollment
1140
Registered
2003-04-03
Start date
1998-09-30
Completion date
Unknown
Last updated
2007-09-18

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

Conditions

HIV Infections, Pulmonary Tuberculosis

Keywords

Vitamin A

Brief summary

The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.

Detailed description

By the year 2000, 13.8 % of individuals with HIV will be co-infected with tuberculosis (TB). Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple, inexpensive intervention is available. Prior to the discovery of antibiotic treatment, cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB. Vitamin A is essential for normal immune function, and Vitamin A supplementation is used in many countries to reduce mortality in children. Vitamin A deficiency in HIV infected people has been associated with increased mortality in the United States, Haiti, Malawi, and Uganda. This study will determine whether daily Vitamin A supplementation, given concurrently with TB chemotherapy, will reduce mortality in adults with HIV and TB. All study participants will receive standard TB chemotherapy (isoniazid, rifampicin, streptomycin, pyrazinamide) for the first 2 months, followed by isoniazid and ethambutol for the following 6 months. Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo. Participants will be followed for 24 months after study enrollment.

Interventions

DRUGmultivitamin

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Sputum-confirmed pulmonary tuberculosis * Resident of Zomba or Blantyre Districts, Malawi * Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme

Exclusion criteria

* Prior treatment for tuberculosis

Design outcomes

Primary

MeasureTime frame
Mortality

Secondary

MeasureTime frame
Morbidity

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026