- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213161
Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.
Study Overview
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maharashtra
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Pune, Maharashtra, India
- King Edward Memorial Hospital (KEM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 6-18 months of age
- anemic (Hb 70-100g/L)
- ingesting weaning food in addition to breast milk
- free from major illness (including symptomatic for malaria) and afebrile
- living within study area for the next two months
- parental consent obtained
- only one child per household in the study
Exclusion Criteria:
- Hb < 70 or ≥ 100 g/L
- Not receiving any complementary foods
- Receiving an iron supplement within two weeks of the date of enrolment
- chronic illness
- severely malnourished: weight for age z-score < -3.0
- another child in the household is a subject in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
|
Secondary Outcome Measures
Outcome Measure |
---|
Ferritin at 8 weeks
|
Serum Transferrin Receptor (sTfR) at 8 weeks
|
side effects every 2 weeks
|
compliance with iron supplement assessed every 2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stanley Zlotkin, PhD, MD, The Hospital For Sick Children
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000001031
- CIHR: GLH-63082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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