An interventional study of fish oil and folate in Perinatal DHA and Folate Status and Neurological Development, sponsored by Ludwig-Maximilians - University of Munich. Completed at 3 sites in 3 countries. Open to female participants aged 18 Years to 41 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-30.
Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Treatment
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.
1,925 studies on the registry are indexed under Hypersensitivity; 261 are open to participants now.
This study's enrollment of 315 is above the median of 58 across 1,391 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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
Dietary Supplement: fish oil
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
Dietary Supplement: 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
Dietary Supplement: fish oil + folate
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery
Dietary Supplement: placebo
400 mg of DHA and 150 mg of eicosapentaenoic acid per day
400 µg per day
Drug pages: Fish Oils · Folic Acid
500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
only vitamins and minerals as recommended, but no fish oil or folate
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
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
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fish Oils · Folic Acid
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