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Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213161
First received: September 13, 2005
Last updated: October 10, 2006
Last verified: September 2005
History of Changes
  Purpose

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.


Condition Intervention
Anemia
 Drug: iron supplement, iron drops

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing

Secondary Outcome Measures:
  • Ferritin at 8 weeks
  • Serum Transferrin Receptor (sTfR) at 8 weeks
  • side effects every 2 weeks
  • compliance with iron supplement assessed every 2 weeks

Estimated Enrollment: 425
Study Start Date: August 2004
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213161

Locations
India
King Edward Memorial Hospital (KEM)
Pune, Maharashtra, India
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Stanley Zlotkin, PhD, MD The Hospital for Sick Children
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213161     History of Changes
Other Study ID Numbers: 1000001031, CIHR: GLH-63082
Study First Received: September 13, 2005
Last Updated: October 10, 2006
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
anemia
iron deficiency
iron drops
 iron supplement
malnutrition
pediatrics

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
 Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013