Fish Oil and Folate Supplementation During Pregnancy

Ludwig-Maximilians - University of Munich315 enrolled

Overview

Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood. Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

315

Conditions

Perinatal DHA and Folate Status Neurological Development

Interventions

fish oilDIETARY_SUPPLEMENT

400 mg of DHA and 150 mg of eicosapentaenoic acid per day

folateDIETARY_SUPPLEMENT

400 µg per day

fish oil + folateDIETARY_SUPPLEMENT

500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 41 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * singleton pregnancy * gestation \<20 week at enrollment * intention to deliver in one of the study centers * body weight at time of enrollment from 50 kg to 92 kg Exclusion Criteria: * serious chronic illness (eg, diabetes, hepatitis) * use fish oil supplements since the beginning of pregnancy * use of folate or vitamin B-12 supplements after gestation week 16

Locations (3)

Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University

Munich, Germany

University of Pecs

Pécs, Hungary

Department of Paediatrics, University of Granada

Granada, Spain

Outcomes

Primary Outcomes

percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood

the biochemical efficacy of supplementation during pregnancy is tested by measuring the DHA content of cord blood phospholipids, as direct supplementation (fish oil) or increased perfusion of the placenta (MTHF) could both influence this parameter

Time frame: labour

Secondary Outcomes

neurological and cognitive development of the offspring

non invasive, age adequate, tests of neurological and cognitive function are performed at various ages of the offspring

Time frame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years

weight development

body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined

Time frame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years

height

body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years

Time frame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years

life style and diet

information on medical history, life sytyle and dietary habits is collected via questionnaires and non invasivly collected of biological samples (urine, cheek cells)

Time frame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years

electroencephalography (EEG)

at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests

Time frame: age 8 years and 9.5 years

Data from ClinicalTrials.gov

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