NCT01180933

Fish Oil and Folate Supplementation During Pregnancy

Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Accepted

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.

Conditions

• Perinatal DHA and Folate Status
• Neurological Development

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	fish oil	400 mg of DHA and 150 mg of eicosapentaenoic acid per day
DIETARY_SUPPLEMENT	folate	400 µg per day
DIETARY_SUPPLEMENT	fish oil + folate	500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
DIETARY_SUPPLEMENT	placebo	only vitamins and minerals as recommended, but no fish oil or folate

Timeline

• Start date: 2001-11-01
• Primary completion: 2003-08-01
• Completion: 2013-03-01
• First posted: 2010-08-12
• Last updated: 2014-07-30

Locations

3 sites across 3 countries: Germany, Hungary, Spain