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

Primary Purpose

Anemia

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
iron supplement, iron drops
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring anemia, iron deficiency, iron drops, iron supplement, malnutrition, pediatrics

Eligibility Criteria

6 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Edward Memorial Hospital (KEM)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ferritin at 8 weeks
Serum Transferrin Receptor (sTfR) at 8 weeks
side effects every 2 weeks
compliance with iron supplement assessed every 2 weeks

Full Information

First Posted
September 13, 2005
Last Updated
April 14, 2021
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00213161
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
anemia, iron deficiency, iron drops, iron supplement, malnutrition, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
425 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
iron supplement, iron drops
Primary Outcome Measure Information:
Title
Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
Secondary Outcome Measure Information:
Title
Ferritin at 8 weeks
Title
Serum Transferrin Receptor (sTfR) at 8 weeks
Title
side effects every 2 weeks
Title
compliance with iron supplement assessed every 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Zlotkin, PhD, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Edward Memorial Hospital (KEM)
City
Pune
State/Province
Maharashtra
Country
India

12. IPD Sharing Statement

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

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