Status:
COMPLETED
Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial
Lead Sponsor:
Society for Applied Studies
Collaborating Sponsors:
World Health Organization
Linda and Kenneth Pollin Foundation, Inc.
Conditions:
Diarrhea
Respiratory Infection
Eligibility:
All Genders
14-28 years
Phase:
NA
Brief Summary
There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly imp...
Detailed Description
A double blind, randomized, placebo controlled trial is being conducted in which the unit of randomization is 14-28 days old infants. Infants in the intervention group receive 1 RDA of elemental zinc ...
Eligibility Criteria
Inclusion
- Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (\<10th percentile of the National Center for Health Statistics \[NCHS\] median birth weight)
- Either sex
- Resides within 7 km of the hospital
Exclusion
- Likely to leave the area of residence within 6 months of enrollment
- Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
- Non consent for participation
- Illness requiring hospitalization
- Twins
- Preterm
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00272142
Start Date
January 1 2005
End Date
August 1 2007
Last Update
September 3 2009
Active Locations (1)
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1
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, India, 110017