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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:
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

September 2, 2005
August 12, 2009
May 2005
August 2007   (final data collection date for primary outcome measure)
weight gain in childhood tuberculosis [ Time Frame: 2 months after start of anti-tuberculosis therapy. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00145184 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
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Effect of Multivitamin Supplements on Clinical and Immunological Response in Childhood Tuberculosis
Effect of Multivitamin Supplements on Clinical and Immunological Response in Childhood Tuberculosis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tuberculosis
  • 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.
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Multivitamins
    Multivitamin supplement containing the following vitamins: B1, B2, Niacin, B6, Folate, B12, C, and E
    Intervention: Dietary Supplement: Multivitamin supplement containing vitamins B, C, and E
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
August 2010
August 2007   (final data collection date for primary outcome measure)

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

Both
6 Weeks to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00145184
03-117
Yes
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Wafaie Fawzi, MD, DrPH Harvard School of Public Health
Harvard School of Public Health
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP