This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Fish Oil Supplementation in Lactation

This study has been completed.
Danish Research Agency
Technical University of Denmark
Information provided by:
University of Copenhagen Identifier:
First received: December 15, 2005
Last updated: August 12, 2008
Last verified: August 2008
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
Intervention Model: Parallel Assignment
Masking: Double
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:


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.


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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00266305

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

Responsible Party: Associate profesor lotte lauritzen, Dept. of Human Nutrition, University of Copenhagen 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

Keywords provided by University of Copenhagen:
Infant development
Visual acuity
Immune function
Breast milk processed this record on September 19, 2017