Status:
COMPLETED
Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
University of Bergen
Conditions:
Tuberculosis
Eligibility:
All Genders
6-15 years
Phase:
PHASE3
Brief 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...
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 a...
Eligibility Criteria
Inclusion
- New pulmonary (including pleural) tuberculosis with/without an extrapulmonary lesion in children age 6 months to 15 years
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00801606
Start Date
December 1 2008
End Date
June 1 2012
Last Update
February 10 2016
Active Locations (1)
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1
Department of Pediatrics, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029