Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Zinc; Micronutrient without zinc; Micronutrient with zinc; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Zinc 20 mg/day; Multimineral 2 RDA; Multimineral 2 RDA and zinc 20 mg per day; Placebo
Other intervention name(s): study drug; study drug; study drug; study drug
Intervention MeSH terms: Zinc; Trace Elements; Micronutrients
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Micronutrient; Childhood Tuberculosis