Status:
COMPLETED
Iron Treatment for Young Children With Non-anemic Iron Deficiency
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Mead Johnson Nutrition
Conditions:
Non-anemic Iron Deficiency
Eligibility:
All Genders
12-40 years
Phase:
NA
Brief Summary
The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (fami...
Eligibility Criteria
Inclusion
- Age between 12 and 40 months attending any well child visit
- Informed parental consent
Exclusion
- developmental disorder
- genetic, chromosomal or syndromic condition
- chronic medical condition (with the exception of asthma and allergies)
- chronic anemia, iron deficiency, or recent oral iron supplementation or treatment
- prematurity, with a gestational age of less than 35 weeks
- low birth weight less than 2,500 g;
- attending the office for an acute illness, such as a viral illness, or other health concern other than for a well-child assessment
- any contraindications to receiving elemental iron
- the use of any natural health product containing the same medicinal ingredient(s) as the investigational product
- English is not spoken to the child in the home or in a child care setting
- CRP level ≥10 mg/L
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01481766
Start Date
June 1 2012
End Date
December 1 2018
Last Update
October 30 2025
Active Locations (2)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8