Fish Oil Supplementation in Lactation

Development and Health Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266305
• Other study ID #: KVL-IHE-D72
• Secondary ID: FØTEK 2: 93s-246
• Status: Completed
• Phase: N/A
• First received: December 15, 2005
• Last updated: August 12, 2008
• Start date: December 1998
• Est. completion date: January 2007

Study information

• Verified date: August 2008
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Development and Health

Intervention

Behavioral:
• Fish oil (Dry n-3, BASF)
5 g/oil daily for the first four month of lactation

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	BASF, Danish Research Agency, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

Hoppe C, Udam TR, Lauritzen L, Mølgaard C, Juul A, Michaelsen KF. Animal protein intake, serum insulin-like growth factor I, and growth in healthy 2.5-y-old Danish children. Am J Clin Nutr. 2004 Aug;80(2):447-52. — View Citation

Larnkjaer A, Christensen JH, Michaelsen KF, Lauritzen L. Maternal fish oil supplementation during lactation does not affect blood pressure, pulse wave velocity, or heart rate variability in 2.5-y-old children. J Nutr. 2006 Jun;136(6):1539-44. — View Citation

Lauritzen L, Hoppe C, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation and growth during the first 2.5 years of life. Pediatr Res. 2005 Aug;58(2):235-42. Epub 2005 Jul 8. — View Citation

Lauritzen L, Jørgensen MH, Mikkelsen TB, Skovgaard lM, Straarup EM, Olsen SF, Høy CE, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on visual acuity and n-3 fatty acid content of infant erythrocytes. Lipids. 2004 Mar;39(3):195-206. — View Citation

Lauritzen L, Jørgensen MH, Olsen SF, Straarup EM, Michaelsen KF. Maternal fish oil supplementation in lactation: effect on developmental outcome in breast-fed infants. Reprod Nutr Dev. 2005 Sep-Oct;45(5):535-47. — View Citation

Lauritzen L, Kjaer TM, Fruekilde MB, Michaelsen KF, Frøkiaer H. Fish oil supplementation of lactating mothers affects cytokine production in 2 1/2-year-old children. Lipids. 2005 Jul;40(7):669-76. — View Citation

Ulbak J, Lauritzen L, Hansen HS, Michaelsen KF. Diet and blood pressure in 2.5-y-old Danish children. Am J Clin Nutr. 2004 Jun;79(6):1095-102. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast milk fatty acid composition - 0, 2, 4 and 9 mo
Primary	Fatty acid composition of infant RBC at 4 mo
Primary	Visual acuity - 2 and 4 mo
Primary	Follow-up:
Primary	Anthropometric measures
Primary	Blood pressure
Primary	Ex vivo cytokine production (e.g. IL-10 and interferon-?) in whole blood after 24 h of stimulation with bacterial components
Secondary	Anthropometric measures - 0, 2, 4 and 9 mo
Secondary	Problem solving at 9 mo
Secondary	Language development (CDI) at 1 and 2 y
Secondary	Contrast sensitivity at 2 mo
Secondary	Vernier acuity at 4 mo
Secondary	Follow-up:
Secondary	Heart rate variability
Secondary	Endothelial function measured by PWV
Secondary	Plasma IgE
Secondary	Diet
Secondary	RBC fatty acid composition
Secondary	Plasma growth factors