Vitamin A Therapy for Tuberculosis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00057434
First received: April 1, 2003
Last updated: September 17, 2007
Last verified: August 2007

April 1, 2003
September 17, 2007
September 1998
Not Provided
Mortality
Not Provided
Complete list of historical versions of study NCT00057434 on ClinicalTrials.gov Archive Site
Morbidity
Not Provided
Not Provided
Not Provided
 
Vitamin A Therapy for Tuberculosis
Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pulmonary Tuberculosis
  • HIV Infections
Drug: multivitamin
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1140
Not Provided
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00057434
5R01AI41956-05
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Richard D. Semba, MD Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP