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

April 14, 2021 updated by: Stanley Zlotkin, The Hospital for Sick Children

Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India
        • King Edward Memorial Hospital (KEM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Stanley Zlotkin, PhD, MD, The Hospital For Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

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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