Status:
COMPLETED
Fish Oil Supplementation in Lactation
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Danish Research Agency
BASF
Conditions:
Development and Health
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The main purpose of the study was to examine whether fish oil supplementation of lactating mothers affect infant development during first year of life, focusing on visual and mental development. A fol...
Detailed Description
Background: Studies indicate that infants, who are fed formula without n-3 LCPUFA, have slower visual development than those, who receive n-3 LCPUFA in breast-milk. The mental development seems also ...
Eligibility Criteria
Inclusion
- Pregnant women with uncomplicated singleton pregnancy
- No metabolic disorders and prepregnancy BMI \< 30 kg/m2
- Intention to exclusively breast-feed for 4 mo
- Fish intake below the Danish mean or above 80th percentile (reference group)
Exclusion
- Pre- or post term delivery (\< 37 or \> 43 wks of gestation)
- Abnormal weight for gestation (outside 10th-90th percentile range)
- Apgar score 5 min after delivery \< 8
- Infant admission to a neonatal department
- If supplementation did not begin within 2 wks after delivery
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00266305
Start Date
December 1 1998
End Date
January 1 2007
Last Update
August 14 2008
Active Locations (1)
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1
Department of Human Nutrition
Frederiksberg, Denmark, DK-1958