Viewing Study NCT00213161



Ignite Creation Date: 2024-05-05 @ 12:01 PM
Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00213161
Status: COMPLETED
Last Update Posted: 2021-04-19
First Post: 2005-09-13

Brief Title: Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
Sponsor: The Hospital for Sick Children
Organization: The Hospital for Sick Children

Study Overview

Official Title: Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India
Status: COMPLETED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CIHR GLH-63082 None None None