Fish Oil Supplementation in Lactation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Development and Health

Intervention / Treatment
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* Behavioral: Fish oil (Dry n-3, BASF)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil<br> | Behavioral: Fish oil (Dry n-3, BASF)<br>* 5 g/oil daily for the first four month of lactation<br>|
| Placebo Comparator: Olive oil<br>Control group | Behavioral: Fish oil (Dry n-3, BASF)<br>* 5 g/oil daily for the first four month of lactation<br>|
| No Intervention: High fish<br>Reference group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n-3 LCPUFA, Infant development, Visual acuity, Immune function, Breast milk