Neurological Development Clinical Trial
— NUHEALOfficial title:
Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
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.
| Status | Completed |
| Enrollment | 315 |
| Est. completion date | March 2013 |
| Est. primary completion date | August 2003 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 41 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University | Munich | |
| Hungary | University of Pecs | Pecs | |
| Spain | Department of Paediatrics, University of Granada | Granada |
| Lead Sponsor | Collaborator |
|---|---|
| Ludwig-Maximilians - University of Munich | European Union |
Germany, Hungary, Spain,
Krauss-Etschmann S, Shadid R, Campoy C, Hoster E, Demmelmair H, Jiménez M, Gil A, Rivero M, Veszprémi B, Decsi T, Koletzko BV; Nutrition and Health Lifestyle (NUHEAL) Study Group. Effects of fish-oil and folate supplementation of pregnant women on materna — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | labour | No |
| Secondary | 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 | age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years | No |
| Secondary | weight development | body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined | age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years | No |
| Secondary | height | body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years | age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years | No |
| Secondary | 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) | age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years | No |
| Secondary | electroencephalography (EEG) | at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests | age 8 years and 9.5 years | No |