Vitamin A Therapy for Tuberculosis - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00057434

Purpose

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.

Condition	Intervention	Phase
Pulmonary Tuberculosis HIV Infections	Drug: multivitamin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS

Resource links provided by NLM:

MedlinePlus related topics: AIDS Tuberculosis

Drug Information available for: Retinol Vitamin A

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Mortality

Secondary Outcome Measures:

Morbidity

Estimated Enrollment:	1140
Study Start Date:	September 1998

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057434

Locations

Malawi
Zomba Central Hospital
Zomba, Malawi

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Richard D. Semba, MD

Johns Hopkins University

More Information

No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	5R01AI41956-05
Study First Received:	April 1, 2003
Last Updated:	September 17, 2007
ClinicalTrials.gov Identifier:	NCT00057434 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Vitamin A

Additional relevant MeSH terms:

Bacterial Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Physiological Effects of Drugs
Infection
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamins
Tuberculosis
Micronutrients
Retroviridae Infections
RNA Virus Infections
Immune System Diseases

Growth Substances
Acquired Immunodeficiency Syndrome
Pharmacologic Actions
Immunologic Deficiency Syndromes
Actinomycetales Infections
Virus Diseases
HIV Infections
Lung Diseases
Vitamin A
Sexually Transmitted Diseases
Tuberculosis, Pulmonary
Lentivirus Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 30, 2009