NCT00801606

Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis

Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

We plan to do a randomized controlled trial to study impact of multimineral supplement with antituberculosis drugs in freshly diagnosed pulmonary tuberculosis in children. Plan to enrol 400 children at two sites in Delhi. The diagnosis and treatment of pulmonary tuberculosis will be based on recommendations of Revised National Tuberculosis Control Program (RNTCP). The outcome will be measured in form of weight gain and improvement in x ray film of chest. The secondary outcome variables will be as follows: 1. Effect of micronutrient supplements at 2 and 6 months on anthropometric parameters by comparing means of anthropometric parameters in different groups. 2. Improvement in radiological findings at 2 months: Comparing the proportion of children showing clearance of X ray films at baseline and 6 months by two paediatricians independently using same protocol. 3. Resolution of symptoms at 2 and 6 months: By comparing proportion of patients having resolution of presenting symptoms (fever, cough, appetite improvement) as reported by parents 4. Proportion of children requiring extension of intensive phase of therapy: Comparing proportion of children in different groups requiring extension of intensive phase of therapy at 2 months due to the treating physician's decision. 5. Interferon gamma responses to M. tuberculosis antigens ESAT6 and CF10 by quantiferon assay at baseline, 2 months and 6 months of treatment 6. To study effect of zinc supplementation on ocular toxicity in children receiving ethambutol by VER 7. To document drug resistance (S, I, R, E) patterns among children with culture confirmed TB 8. To document genotypic strain diversity among children with culture confirmed TB, also associations between strain type and disease severity and/or drug resistance 9. To document the spectrum of mycobacterial species by culture in children clinically suspected of having pulmonary tuberculosis.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-12-03
• Last updated: 2016-02-10

Locations

1 site across 1 country: India