Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi