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

• Status: Terminated
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• Loss of more than 10% of maximum weight or failure to gain weight for 2 months.

• Having cough with wheeze for 4 weeks or more.

• History of household contact with a probable or confirmed tuberculosis case in the past 6 months.

• Pyrexia of unknown origin.

• Painless swelling in a group of cervical lymph nodes.

• Children who were diagnosed with TB in the past 5 years and have received anti-tuberculosis therapy for a period less than 4 weeks.

Exclusion Criteria:

-Children who have been treated with anti-tuberculosis therapy exceeding 4 weeks in the past one year will not be eligible for entry into the study