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

NCT ID: NCT00213161

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2005-06-30

Brief 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.

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

iron supplement, iron drops

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Stanley Zlotkin

Chief, Global Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanley Zlotkin, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

King Edward Memorial Hospital (KEM)

Pune, Maharashtra, India

Countries

India

Other Identifiers

CIHR: GLH-63082

Identifier Type: -

Identifier Source: secondary_id

1000001031

Identifier Type: -

Identifier Source: org_study_id