Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.|
- Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
- Ferritin at 8 weeks
- Serum Transferrin Receptor (sTfR) at 8 weeks
- side effects every 2 weeks
- compliance with iron supplement assessed every 2 weeks
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||June 2005|
Iron deficiency anemia affects two thirds of children in most developing nations, and even mild anemia can have serious implications for child development. In India, government programs within India have been ineffective in controlling this public health problem due to the lack of effective iron supplements reaching children.
Our research group developed 'Sprinkles', an inexpensive micronutrient supplement which is a single-serve sachet of tasteless powder that contain encapsulated iron and other micronutrients. Parents can be easily instructed to mix the contents of one sachet into a bowl of any complementary food.
This study is part of a partnership and capacity development between interdisciplinary research groups at The Hospital for Sick Children, University of Toronto, Canada and the King Edward Memorial Hospital in India, aimed at developing a long-term program of research that will address iron deficiency anemia among infants and young children in India. For Sprinkles to be implemented into national programs in India, a comprehensive strategy is needed which includes a single, safe and effective iron dose for the Indian population.
This specific study is to conduct a community-based, randomized clinical trial in India to determine the appropriate dose of supplementation required for the target age group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213161
|King Edward Memorial Hospital (KEM)|
|Pune, Maharashtra, India|
|Principal Investigator:||Stanley Zlotkin, PhD, MD||The Hospital for Sick Children|