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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:
ClinicalTrials.gov Identifier:
NCT00213161
First Posted: September 21, 2005
Last Update Posted: October 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: Single
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00213161     History of Changes
Other Study ID Numbers: 1000001031
CIHR: GLH-63082
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 11, 2006
Last Verified: September 2005

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