Skip to main content
OpenTrials
Completed

NCT Number: NCT00057434

Vitamin A Therapy for Tuberculosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Mycobacterium Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tuberculosis Tuberculosis, Pulmonary Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zomba Central Hospital

Zomba, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multivitamin

Drug

Primary outcomes

  1. Mortality

Secondary outcomes

  1. Morbidity

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS

Important dates

Study start
1998
First posted
Apr 3, 2003
Registry last updated
Sep 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.