Status:
COMPLETED
Fish Oil and Folate Supplementation During Pregnancy
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
European Union
Conditions:
Perinatal DHA and Folate Status
Neurological Development
Eligibility:
FEMALE
18-41 years
Phase:
NA
Brief 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 blo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT01180933
Start Date
November 1 2001
End Date
March 1 2013
Last Update
July 30 2014
Active Locations (3)
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1
Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University
Munich, Germany, 80337
2
University of Pecs
Pécs, Hungary, 7623
3
Department of Paediatrics, University of Granada
Granada, Spain, 18012