132
Participants
Start Date
June 30, 2012
Primary Completion Date
October 31, 2018
Study Completion Date
December 31, 2018
Ferrous Sulfate
6 mg elemental iron/kg/day (0.4 ml/kg/day) in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling
Placebo
0.4 ml/kg/day in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling
Dietary counseling
Dietary counseling will include written recommendations regarding maximum daily cow's milk intake, varied solid food intake including high iron containing foods, and avoidance of foods which reduce iron absorption.
St. Michael's Hospital, Toronto
The Hospital for Sick Children, Toronto
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Mead Johnson Nutrition
INDUSTRY
Mount Sinai Hospital, Canada
OTHER
Unity Health Toronto
OTHER
The Hospital for Sick Children
OTHER