Fish Oil Supplementation in Lactation

This study has been completed.
Sponsor:
Collaborators:
Danish Research Agency
BASF
Technical University of Denmark
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00266305
First received: December 15, 2005
Last updated: August 12, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Development and Health
Behavioral: Fish oil (Dry n-3, BASF)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Breast milk fatty acid composition - 0, 2, 4 and 9 mo
  • Fatty acid composition of infant RBC at 4 mo
  • Visual acuity - 2 and 4 mo
  • Follow-up:
  • Anthropometric measures
  • Blood pressure
  • Ex vivo cytokine production (e.g. IL-10 and interferon-γ) in whole blood after 24 h of stimulation with bacterial components

Secondary Outcome Measures:
  • Anthropometric measures - 0, 2, 4 and 9 mo
  • Problem solving at 9 mo
  • Language development (CDI) at 1 and 2 y
  • Contrast sensitivity at 2 mo
  • Vernier acuity at 4 mo
  • Follow-up:
  • Heart rate variability
  • Endothelial function measured by PWV
  • Plasma IgE
  • Diet
  • RBC fatty acid composition
  • Plasma growth factors

Estimated Enrollment: 150
Study Start Date: December 1998
Estimated Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: Fish oil Behavioral: Fish oil (Dry n-3, BASF)
5 g/oil daily for the first four month of lactation
Placebo Comparator: Olive oil
Control group
Behavioral: Fish oil (Dry n-3, BASF)
5 g/oil daily for the first four month of lactation
No Intervention: High fish
Reference group

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266305

Locations
Denmark
Department of Human Nutrition
Frederiksberg, Denmark, DK-1958
Sponsors and Collaborators
University of Copenhagen
Danish Research Agency
BASF
Technical University of Denmark
Investigators
Principal Investigator: Lotte Lauritzen, Ph.D Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark
  More Information

Publications:
Responsible Party: Associate profesor lotte lauritzen, Dept. of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00266305     History of Changes
Other Study ID Numbers: KVL-IHE-D72, FØTEK 2: 93s-2468-å96-00020, FØTEK 3: 2011-00-0028, KF 01-300/98, KF 01-183/01
Study First Received: December 15, 2005
Last Updated: August 12, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
n-3 LCPUFA
Infant development
Visual acuity
Immune function
Breast milk

ClinicalTrials.gov processed this record on April 17, 2014