NCT00145184

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

September 2, 2005

Last Update Submit

March 28, 2015

Conditions

Tuberculosis

Keywords

multivitamin, supplements, tuberculosis, Tanzania

Outcome Measures

Primary Outcomes (1)

  • weight gain in childhood tuberculosis

    2 months after start of anti-tuberculosis therapy.

Secondary Outcomes (2)

  • clearance of chest x-ray in childhood tuberculosis

    2 months after start of anti-tuberculosis therapy

  • immunological parameters: ex-vivo lymphocyte proliferation; cytokines production including IL-2, IL-12, TNF - alpha, interferon-gamma; and CD4 and CD8 T-lymphocyte counts

    2 months after start of anti-tuberculosis therapy

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Multivitamins

EXPERIMENTAL

Multivitamin supplement containing the following vitamins: B1, B2, Niacin, B6, Folate, B12, C, and E

Dietary Supplement: Multivitamin supplement containing vitamins B, C, and E

Interventions

Multivitamin supplement containing vitamins B, C, and EDIETARY_SUPPLEMENT

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.

Multivitamins
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age6 Weeks - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University, College of Health Sciences

Dar es Salaam, Tanzania

Location

Related Publications (1)

  • Mehta S, Mugusi FM, Bosch RJ, Aboud S, Chatterjee A, Finkelstein JL, Fataki M, Kisenge R, Fawzi WW. A randomized trial of multivitamin supplementation in children with tuberculosis in Tanzania. Nutr J. 2011 Oct 31;10:120. doi: 10.1186/1475-2891-10-120.

    PMID: 22039966DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Wafaie Fawzi, MD, DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Global Health and Population

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

May 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

TA(1)