CompletedNot Applicable

Fish Oil and Folate Supplementation During Pregnancy

Germany, Hungary, Spain315 participantsStarted 2001-11

Plain-language summary

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.

Who can participate

Age range18 Years – 41 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: labour

Trial details

NCT IDNCT01180933

SponsorLudwig-Maximilians - University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2003-08

View on ClinicalTrials.gov More Perinatal DHA and Folate Status trials