TB Nutrition, Immunology and Epidemiology

NCT00170404 | Completed Phase 3

• 1 other identifier: 00-032
• Study Type: interventional
• Target: 887
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether people who take vitamins along with the standard medicine for tuberculosis (TB) recover better and quicker than people who take only the standard medicine for TB. This study will enroll 600 men and women, who are age 18-65 years, have TB, and intend to stay in Dar-es-Salaam for at least 2 years from the start of TB therapy. Half the participants will have active TB and also HIV infection, and the other half will have TB alone. Half the volunteers will be given vitamins, and the other half will be given placebo (sugar pill with no vitamins) from the start of their TB therapy, through the 8 months of anti-TB therapy, and up to 48 months. Participation in the study involves visits to the clinic, physical exams, home visits, and answering questions about personal health, foods eaten, household, occupation, and education. Volunteers will also provide blood, sputum, and urine samples.

Conditions

Mycobacterium Tuberculosis

Keywords

HIV Infections, Tuberculosis, Malnutrition, Tanzania

Interventions

Folic Acid DRUG

Micronutrients: Vitamins B1, B2, B6, Niacin, B12, C, E. DRUG

Selenium DRUG

Vitamin A DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 18 to 65 years inclusive
• At least two positive sputum smears for tuberculosis (TB)
• Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
• Subjects who grant informed consent to participation
• Subject is assigned to a treatment clinic where International Collarborations in Infectious Disease Research (ICIDR) staff can follow that patient, either at that clinic directly, or through referral to a nearby clinic for research visits.

You may not qualify if:

• Karnofsky score \< 40%
• Hemoglobin \< 8.5 g/dl
• Having had treatment for TB exceeding 4 weeks in the last 5 years
• Pregnant women: Women who are pregnant at the time of enrollment will also be excluded, given that all pregnant women receive folate and iron supplements as part of routine prenatal services. Also, it is not possible to enroll enough pregnant women to examine the effect of the supplements in this subset.
• Patient is mentally incapable of understanding the consent form; patient is a prisoner or in police custody; or patient is deaf/dumb.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Muhimbili University, College of Health Sciences

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

HIV Infections; Tuberculosis; Malnutrition

Interventions

Folic Acid; Niacin; Vitamin B 12; Selenium; Vitamin A

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds; Chalcogens; Elements; Inorganic Chemicals; Minerals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2000
• Study Completion: October 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2007-02

Locations

TA (1)