Fish Oil and Folate Supplementation During Pregnancy
- Conditions
- Neurological DevelopmentPerinatal DHA and Folate Status
- Interventions
- Dietary Supplement: fish oilDietary Supplement: fish oil + folateDietary Supplement: folateDietary Supplement: placebo
- Registration Number
- NCT01180933
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 315
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fish oil fish oil the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA and 150 eicosapentaenoic acid per day from gestational week 22 until delivery fish oil + folate fish oil + folate the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA, 150 mg eicosapentaenoic acid and 400 µg MTHF per day from gestational week 22 until delivery folate folate the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 400 µg folate (methyltetrahydrofolate)per day from gestational week 22 until delivery placebo placebo the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery
- Primary Outcome Measures
Name Time Method percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood labour 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
- Secondary Outcome Measures
Name Time Method neurological and cognitive development of the offspring age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years non invasive, age adequate, tests of neurological and cognitive function are performed at various ages of the offspring
weight development age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined
life style and diet age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years information on medical history, life sytyle and dietary habits is collected via questionnaires and non invasivly collected of biological samples (urine, cheek cells)
height age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
electroencephalography (EEG) age 8 years and 9.5 years at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests
Trial Locations
- Locations (3)
Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University
🇩🇪Munich, Germany
Department of Paediatrics, University of Granada
🇪🇸Granada, Spain
University of Pecs
🇭🇺Pecs, Hungary