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

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00145184
First received: September 2, 2005
Last updated: August 12, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Tuberculosis
 Dietary Supplement: Multivitamin supplement containing vitamins B, C, and E
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Multivitamin Supplements on Clinical and Immunological Response in Childhood Tuberculosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • weight gain in childhood tuberculosis [ Time Frame: 2 months after start of anti-tuberculosis therapy. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clearance of chest x-ray in childhood tuberculosis [ Time Frame: 2 months after start of anti-tuberculosis therapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2005
Estimated Study Completion Date: August 2010
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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.

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145184

Locations
Tanzania
Muhimbili University, College of Health Sciences
Dar Es Salaam, Tanzania
Sponsors and Collaborators
Harvard School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Wafaie Fawzi, MD, DrPH Harvard School of Public Health
  More Information

No publications provided by Harvard School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00145184     History of Changes
Obsolete Identifiers: NCT00197535
Other Study ID Numbers: 03-117
Study First Received: September 2, 2005
Last Updated: August 12, 2009
Health Authority: United States: Federal Government

Keywords provided by Harvard School of Public Health:
multivitamin, supplements, tuberculosis, Tanzania

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013