Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
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|ClinicalTrials.gov Identifier: NCT00213161|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 11, 2006
|Condition or disease||Intervention/treatment|
|Anemia||Drug: iron supplement, iron drops|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||425 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.|
|Study Start Date :||August 2004|
|Estimated Study Completion Date :||June 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213161
|King Edward Memorial Hospital (KEM)|
|Pune, Maharashtra, India|
|Principal Investigator:||Stanley Zlotkin, PhD, MD||The Hospital for Sick Children|