Status:
COMPLETED
Study Comparing Two Isoforms of Vitamin D Supplements for Infants
Lead Sponsor:
McGill University
Collaborating Sponsors:
Canadian Foundation for Dietetic Research (CFDR)
Conditions:
Healthy
Eligibility:
All Genders
2-6 years
Phase:
PHASE3
Brief Summary
There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2 (plant source). Almost all the usual vitamin D preparations for infants available in Canadian pharmacies contain ...
Detailed Description
Vitamin D is important to develop strong bones and teeth as well as to prevent rickets, a childhood bone disease in which the bones get very soft and bend. the investigators know that vitamin D can be...
Eligibility Criteria
Inclusion
- Healthy, singleton term infants of appropriate for gestational age, according to Centers for Disease Control (CDC) growth charts based on weight at birth between 5th and 95th percentiles for sex
- Born to healthy breastfeeding women
- Exclusively breast fed infants from birth, according to WHO definition: breast milk, expressed breast milk, vitamins, minerals and medicine but not including water, breast milk substitutes, other liquids and solid foods.
Exclusion
- Infants of mothers with a history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes (Celiac disease, Crohn's, etc.), due to malabsorption of fat soluble vitamins
- Mothers taking any medications that can affect vitamin D metabolism (anticonvulsants and corticosteroids)
- Mothers taking ≥ 2,000 IU/d of vitamin D from supplementation
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01190137
Start Date
March 1 2010
End Date
December 1 2011
Last Update
March 2 2012
Active Locations (1)
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1
Mary Emily Clinical Nutrition Research Unit
Ste. Anne de Bellevue, Quebec, Canada, H9X 3V9