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OpenTrials
Completed

NCT Number: NCT00213161

Using Iron Supplementation to Decrease Iron Deficiency Anemia in 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.

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Key information

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Memorial Hospital (KEM)

Pune, Maharashtra, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron supplement, iron drops

Drug

Primary outcomes

  1. Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing

Secondary outcomes

  1. Ferritin at 8 weeks

  2. Serum Transferrin Receptor (sTfR) at 8 weeks

  3. side effects every 2 weeks

  4. compliance with iron supplement assessed every 2 weeks

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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