Vitamin A Therapy for Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1140 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Tuberculosis HIV Infections

Keywords

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Vitamin A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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multivitamin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Richard D. Semba, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Zomba Central Hospital

Zomba, , Malawi

Site Status

Countries

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Malawi

References

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Semba RD, Kumwenda J, Zijlstra E, Ricks MO, van Lettow M, Whalen C, Clark TD, Jorgensen L, Kohler J, Kumwenda N, Taha TE, Harries AD. Micronutrient supplements and mortality of HIV-infected adults with pulmonary TB: a controlled clinical trial. Int J Tuberc Lung Dis. 2007 Aug;11(8):854-9.

Reference Type DERIVED

PMID: 17705950 (View on PubMed)

Other Identifiers

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5R01AI041956-05

Identifier Type: NIH

Identifier Source: org_study_id

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