NCT00266305

Fish Oil Supplementation in Lactation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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 follow-up studies are conducted in order to see if early intake of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) have any long-term effects on health, primarily immun function and markers of cardiovascular risk.

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 to depend on whether infants are breast-fed or not. Long-term health has also been proposed to be affected (The infant origin of adult disease hypothesis). It is not clear whether these differences is due to dietary LCPUFA as comparison of breast-fed and formula-fed infants are complicated by the socio-demographic differences that exist between mother, who choose to breast-feed or not. Recent studies indicate that LCPUFA supplementation of formulas has beneficial effects on the visual acuity and mental abilities of infants. The LCPUFA content of breast-milk varies and this could potentially be of importance for infant development. Methods: 211 pregnant women with a high (\>80 percentile) or low (\< mean) fish intake were recruited. After birth mother with low fish intake were randomized to receive 4 g/day of fish oil or olive oil for the first 4 months of the lactation period. 150 mother-infant pairs were followed for 1 year gathering information on maternal n-3 LCPUFA intake and infant development (growth, developmental milestones, visual acuity, cognitive functions and language acquisition). Milk samples were collected at 0, 2, 4 and 9 months and blood samples were taken from the mother and the infant at 4 months of age in order to determine the biochemical effect of the supplementation. The children were followed-up at 2½ years of age and around 7 years of age. The study is performed in association to the National Birth Cohort.

Conditions

• Development and Health

Interventions

Type	Name	Description
BEHAVIORAL	Fish oil (Dry n-3, BASF)	5 g/oil daily for the first four month of lactation

Timeline

• Start date: 1998-12-01
• Completion: 2007-01-01
• First posted: 2005-12-16
• Last updated: 2008-08-14

Locations

1 site across 1 country: Denmark