Perinatal DHA and Folate Status, Neurological Development
Conditions
Keywords
docosahexaenoic acid, folate, neurological development, allergies, long term consequences for the offspring, allergy risk
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.
Interventions
DIETARY_SUPPLEMENTfish oil
400 mg of DHA and 150 mg of eicosapentaenoic acid per day
DIETARY_SUPPLEMENTfolate
400 µg per day
DIETARY_SUPPLEMENTfish oil + folate
500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
DIETARY_SUPPLEMENTplacebo
only vitamins and minerals as recommended, but no fish oil or folate
Sponsors
European Union
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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 |
Countries
Germany, Hungary, Spain
Outcome results
None listed