Status:
COMPLETED
Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Lead Sponsor:
McGill University
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
2-5 years
Phase:
PHASE2
Brief Summary
The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they ha...
Detailed Description
Vitamin D status is currently judged by serum 25(OH)D and the parathyroid hormone (PTH)-25(OH)D dynamic (1). The ultimate effect of vitamin D on human health is a healthy skeleton, which is characteri...
Eligibility Criteria
Inclusion
- Healthy singleton term born infants of appropriate size for gestational age (AGA) according to the Centers for Disease Control growth charts based on weight at birth between the 5th and 95th percentiles for sex; and born to healthy breastfeeding women. This allows us to assess growth and bone mineral accretion without bias of intrauterine growth restriction.
Exclusion
- Infants of mothers with history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes due to malabsorption of vitamin D (celiac disease, Crohn's etc.); and multiple births.
- Should any exclusion criteria be identified after recruitment, the infant will be excluded from the main analyzes, but followed in a separate arm as intent-to-treat.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00381914
Start Date
March 1 2007
End Date
December 1 2011
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 2E3