drugset / Trial / NCT00801606

Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis

NCT00801606

RandomizedFactorialQuadruple-blindTreatment

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.

Timeline

Start
2008-12
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Micronutrient Unknown 2 unknown
Subject Zinc Sulfate Unknown 20 mg

Indications