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

March 28, 2015 updated by: Wafaie Fawzi, Harvard School of Public Health (HSPH)
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Tuberculosis (TB) remains the single most common infectious disease cause of mortality worldwide with evidence that support nutritional status may be associated with poor outcomes in TB patients. Data from observational and limited intervention studies support the hypothesis that nutritional supplements/micronutrients may be beneficial as well as potential treatments in TB. The effect of micronutrient status will be examined in the context of a double blinded placebo controlled randomized trial; 400 tuberculosis patients (age 6 weeks to 5 years) will be randomized to receive either multi-micronutrients or placebo from the start of their anti-TB therapy, through 2 months of their anti-TB therapy. The primary objective is to evaluate the efficacy of a multivitamin supplement containing vitamins B, C and E on weight gain in childhood tuberculosis at 2 months after start of anti-tuberculosis therapy. Secondary objectives are to: evaluate the efficacy of a multivitamin supplement containing vitamins B, C, and E on clearance of chest x-ray in childhood tuberculosis at 2 months after start of anti-tuberculosis therapy; compare the treatment arms with respect to the following immunological parameters: ex-vivo lymphocyte proliferation; cytokines production including IL-2, IL-12, TNF - alpha, INF-gamma; and CD4 and CD8 T-lymphocyte counts at 2 months after start of anti-tuberculosis therapy; assess the validity of Tuberculin Skin Test (TST) for the diagnosis of childhood tuberculosis in a population with high BCG coverage and HIV prevalence; assess the validity and feasibility of using "microscopic observation broth drug susceptibility (MODS) assay" of sputum and gastric aspirates in the diagnosis of childhood tuberculosis; correlate the above-mentioned immunological markers (IL-2, IL-12, INF-gamma and TNF-alpha) with weight gain and chest x-ray at 2 months after start of anti-tuberculosis therapy; and compare the immunological response to a supplement containing vitamins B, C and E in childhood tuberculosis patients with and without HIV infection. The endpoints of interest include immunological parameters like CD4 T lymphocyte count and clinical outcomes such as, weight gain and resolution of chest x-ray after 2 months anti-TB therapy. Researchers will also examine the utility of these immune response parameters as surrogate markers for treatment efficacy in TB, irrespective of nutritional and other risk factors.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar Es Salaam, Tanzania
        • Muhimbili University, College of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo pill taken orally once per day for two months starting at enrollment.
EXPERIMENTAL: Multivitamins
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight gain in childhood tuberculosis
Time Frame: 2 months after start of anti-tuberculosis therapy.
2 months after start of anti-tuberculosis therapy.

Secondary Outcome Measures

Outcome Measure
Time Frame
clearance of chest x-ray in childhood tuberculosis
Time Frame: 2 months after start of anti-tuberculosis therapy
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
Time Frame: 2 months after start of anti-tuberculosis therapy
2 months after start of anti-tuberculosis therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Wafaie Fawzi, MD, DrPH, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 28, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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