Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis

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.

Inclusion criteria

• New pulmonary (including pleural) tuberculosis with/without an extrapulmonary lesion in children age 6 months to 15 years

Exclusion criteria

• Weight for height < 70 % of NCHS median (reason: zinc as per guidelines is given as standard point of care to all severely malnourished children)
• Bilateral pedal oedema
• Known HIV + ve
• Place of residence outside Delhi (including physicians discretion)
• History of previous ATT treatment or INH prophylaxis for more than 48 hours prior to enrollment
• Signs of upper airway obstruction, or an arterial oxygen saturation less than 92% in room air
• Signs of renal, hepatic, or cvs disease
• Unable to attend follow up session for reading of Mantoux tests
• Documented intake of zinc continuously for > 2 weeks in the preceding 4 weeks at enrollment
• CNS, osteo-articular, pericardial, renal TB
• History of contact with a documented case of drug resistant TB