Clinical trial NCT00213161: Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
Official title: Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: anemia
iron deficiency
iron drops
iron supplement
malnutrition
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 425
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
Secondary outcomes:
measure: Ferritin at 8 weeks
measure: Serum Transferrin Receptor (sTfR) at 8 weeks
measure: side effects every 2 weeks
measure: compliance with iron supplement assessed every 2 weeks
Other outcomes:
Locations:
city: Pune
country: India
facility: King Edward Memorial Hospital (KEM)
state: Maharashtra
Study officials:
affiliation: The Hospital for Sick Children
name: Stanley Zlotkin, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: