Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266305
Status:
COMPLETED
Last Update Posted:
2008-08-14
First Post:
2005-12-15
Brief Title:
Fish Oil Supplementation in Lactation
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 gday 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
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 gday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FØTEK 2 93s-2468-å96-00020 | None | None | None |
| FØTEK 3 2011-00-0028 | None | None | None |
| KF 01-30098 | None | None | None |
| KF 01-18301 | None | None | None |