Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis (ICTBSG)
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.
Drug: Multimineral and zinc
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients|
- Change in Z score for weight and improvement in X ray film [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Resolution of symptoms and interferon gamma activity at 2 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||October 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Zinc 20 mg/day
Multimineral 2 RDA
Drug: Multimineral and zinc
Multimineral 2 RDA and zinc 20 mg per day
|Placebo Comparator: 4||
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:
- Effect of micronutrient supplements at 2 and 6 months on anthropometric parameters by comparing means of anthropometric parameters in different groups.
- 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.
- 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
- 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.
- Interferon gamma responses to M. tuberculosis antigens ESAT6 and CF10 by quantiferon assay at baseline, 2 months and 6 months of treatment
- To study effect of zinc supplementation on ocular toxicity in children receiving ethambutol by VER
- To document drug resistance (S, I, R, E) patterns among children with culture confirmed TB
- To document genotypic strain diversity among children with culture confirmed TB, also associations between strain type and disease severity and/or drug resistance
- To document the spectrum of mycobacterial species by culture in children clinically suspected of having pulmonary tuberculosis.
|Department of Pediatrics, All India Institute of Medical Sciences|
|New Delhi, Delhi, India, 110029|
|Principal Investigator:||Sushil Kr Kabra, MD||All India Institute of Medical Sciences, New Delhi|