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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213161
• Other study ID #: 1000001031
• Secondary ID: CIHR: GLH-63082
• Status: Completed
• Phase: N/A
• Start date: August 2004
• Est. completion date: June 2005

Study information

• Verified date: April 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• iron supplement, iron drops

Locations

Country	Name	City	State
India	King Edward Memorial Hospital (KEM)	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
Secondary	Ferritin at 8 weeks
Secondary	Serum Transferrin Receptor (sTfR) at 8 weeks
Secondary	side effects every 2 weeks
Secondary	compliance with iron supplement assessed every 2 weeks