Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborator: University of Bergen
• Treatments: Micronutrients; Trace Elements; Zinc

Criteria

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