Fish Oil Supplementation in Lactation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00266305
Recruitment Status : Completed
First Posted : December 16, 2005
Last Update Posted : August 14, 2008
Danish Research Agency
Technical University of Denmark
Information provided by:
University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Development and Health Behavioral: Fish oil (Dry n-3, BASF) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : December 1998
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Breast milk fatty acid composition - 0, 2, 4 and 9 mo
  2. Fatty acid composition of infant RBC at 4 mo
  3. Visual acuity - 2 and 4 mo
  4. Follow-up:
  5. Anthropometric measures
  6. Blood pressure
  7. 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 :
  1. Anthropometric measures - 0, 2, 4 and 9 mo
  2. Problem solving at 9 mo
  3. Language development (CDI) at 1 and 2 y
  4. Contrast sensitivity at 2 mo
  5. Vernier acuity at 4 mo
  6. Follow-up:
  7. Heart rate variability
  8. Endothelial function measured by PWV
  9. Plasma IgE
  10. Diet
  11. RBC fatty acid composition
  12. Plasma growth factors

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
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
First Posted: December 16, 2005    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by University of Copenhagen:
Infant development
Visual acuity
Immune function
Breast milk