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Effect of Multivitamin Supplements on Clinical and Immunological Response in Childhood Tuberculosis

NCT00145184 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-31

No results posted yet for this study

Summary

The purpose of this study is to see whether children who take vitamins along with the standard medicine for tuberculosis (TB) recover better and quicker than children who take only the standard medicine for TB. Four hundred children ages 6 weeks-5 years, who have been diagnosed with tuberculosis, will be enrolled. They will be followed for 2 months after treatment for TB. Study procedures may include blood draws, Tuberculin Skin Tests, body measurements, gastric aspirates (removal of stomach fluid), physical exams, and questionnaires. This study will occur in Tanzania.

Conditions

Interventions

DIETARY_SUPPLEMENT

Multivitamin supplement containing vitamins B, C, and E

A daily oral dose of between 1.5 to 3 times the age- appropriate Recommended Dietary Allowance (RDA) of each vitamin taken for two months starting at enrollment.

DRUG

Placebo

Placebo pill taken orally once per day for two months starting at enrollment.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Wafaie Fawzi, MD, DrPH · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • Tanzania

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00145184 on ClinicalTrials.gov