Status:
COMPLETED
Essential Fatty Acid Nutrition For 1-2 Yr-Olds
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
DSM Nutritional Products, Inc.
DSM Food Specialties
Conditions:
Infant Nutrition
Eligibility:
All Genders
12-13 years
Phase:
NA
Brief Summary
This is a prospective longitudinal study that will involve 200 infants enrolled at 12-13 months of age. The study will use a classic nutrition design to assess if infants' feeding practices in Canada ...
Detailed Description
The objectives are to1. determine the change in dietary fat and PUFA intakes, change in biochemical measures of fatty acid status prospectively from enrollment to 24 months-of-age and 2. to use a nutr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- term gestation (37-41 weeks gestation and 2500g or more at birth)
- single birth
- English as the primary language in the home
- non-smoking home environment
- a healthy infant not yet 13 months-of-age, who is not currently breast-fed or fed infant formula with ARA and DHA.
- primary milk source is cows' milk, cows' milk substitutes, or other milk substitutes containing no supplemental fatty acids from enrollment to 24 months-of age.
- the infant has no known food allergies, metabolic, neurological, genetic, or immune disorders that are likely, in the opinion of the investigator to impact the outcome measures in this study.
- the infant has not been fatty acid or oil, including fish oil supplements and there is no intent to provide these supplements during the study.
- the infant has no history of hospitalization, growth failure or any other event which in the opinion of the investigator is likely to impact the outcome measures in this study.
- Exclusion Criteria:
- any infant that does not meet the inclusion criteria will not be included in this study.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01263912
Start Date
December 1 2010
End Date
December 1 2016
Last Update
December 2 2017
Active Locations (1)
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1
BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, Canada, V5Z4H4