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Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis

NCT00801606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2016-02-10

No results posted yet for this study

Summary

A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. There was a substantially larger beneficial effect on survival amongst those who received the combination of Zn and MN compared with those who received either Zn alone or MN alone. These exciting preliminary findings require further confirmation, as the data on mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn supplementation has not been assessed in children with TB. Studies are urgently needed to evaluate the therapeutic potential of nutritional interventions on treatment outcome in children with TB. Simple and inexpensive nutritional interventions may substantially impact TB-related child morbidity and mortality in high-burden settings. The investigators thus, propose a randomized, double blind, controlled trial that will measure the effect of multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed childhood pulmonary TB patients in Delhi.

Conditions

Interventions

DRUG

Zinc

Zinc 20 mg/day

DRUG

Micronutrient without zinc

Multimineral 2 RDA

DRUG

Micronutrient with zinc

Multimineral 2 RDA and zinc 20 mg per day

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Sushil Kr Kabra, MD · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00801606 on ClinicalTrials.gov