Status:
COMPLETED
Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips
Lead Sponsor:
McGill University
Conditions:
Healthy
Eligibility:
All Genders
2-4 years
Phase:
PHASE4
Brief Summary
Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such recommendation is grounded in the fact that the prevalence of rickets in Canada is higher than desirable, ...
Detailed Description
OBJECTIVES 1. To determine parental preference for a new vitamin D delivery system over the standard of care supplement in syrup form. 2. To determine infant acceptance for a new vitamin D delivery s...
Eligibility Criteria
Inclusion
- Healthy singleton newborn infants born at term age of any racial background.
- Infants may be breastfed or formula fed during the study as is safe since the supplement is 400 IU/d and intakes from breast milk or formula will not exceed 400 IU/d for a theoretical total intake of 800 IU/d that is recommended by the Canadian Pediatric Society.
Exclusion
- Infants born prematurely, twins or other multiples.
- Unable to nurse or accept the supplement.
- Congenital malformations.
- Parents not fluent enough in English or French to provide written informed consent.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00846677
Start Date
January 1 2009
End Date
September 1 2009
Last Update
March 2 2012
Active Locations (1)
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1
Mary Emily Clinical Nutrition Research Unit
Sainte-Anne-de-Bellevue, Quebec, Canada, H9X 3V9