NCT00266305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

August 14, 2008

Status Verified

August 1, 2008

First QC Date

December 15, 2005

Last Update Submit

August 12, 2008

Conditions

Development and Health

Keywords

n-3 LCPUFAInfant developmentVisual acuityImmune functionBreast milk

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (3)

Fish oil

EXPERIMENTAL
Behavioral: Fish oil (Dry n-3, BASF)

Olive oil

PLACEBO COMPARATOR

Control group

Behavioral: Fish oil (Dry n-3, BASF)

High fish

NO INTERVENTION

Reference group

Interventions

Fish oil (Dry n-3, BASF)BEHAVIORAL

5 g/oil daily for the first four month of lactation

Fish oilOlive oil

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition

Frederiksberg, DK-1958, Denmark

Location

Related Publications (7)

  • Lauritzen L, Jorgensen MH, Mikkelsen TB, Skovgaard lM, Straarup EM, Olsen SF, Hoy 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. doi: 10.1007/s11745-004-1220-8.

    PMID: 15233397RESULT

  • 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. doi: 10.1203/01.PDR.0000169978.92437.58. Epub 2005 Jul 8.

    PMID: 16006428RESULT

  • Hoppe C, Udam TR, Lauritzen L, Molgaard 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. doi: 10.1093/ajcn/80.2.447.

    PMID: 15277169RESULT

  • 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. doi: 10.1093/ajcn/79.6.1095.

    PMID: 15159241RESULT

  • Lauritzen L, Kjaer TM, Fruekilde MB, Michaelsen KF, Frokiaer H. Fish oil supplementation of lactating mothers affects cytokine production in 2 1/2-year-old children. Lipids. 2005 Jul;40(7):669-76. doi: 10.1007/s11745-005-1429-6.

    PMID: 16196417RESULT

  • Lauritzen L, Jorgensen 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. doi: 10.1051/rnd:2005044.

    PMID: 16188206RESULT

  • 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. doi: 10.1093/jn/136.6.1539.

    PMID: 16702318RESULT

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Lotte Lauritzen, Ph.D

    Department of Human Nutrition, Royal Veterinary and Agricultural University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 16, 2005

Study Start

December 1, 1998

Study Completion

January 1, 2007

Last Updated

August 14, 2008

Record last verified: 2008-08

Locations

DK(1)