Clinical trial NCT01180933: Fish Oil and Folate Supplementation During Pregnancy
Official title: Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal DHA and Folate Status
Neurological Development
Keywords: docosahexaenoic acid
folate
neurological development
allergies
long term consequences for the offspring
allergy risk
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2010-08-12
Enrollment: 315
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
timeFrame: labour
Secondary outcomes:
measure: neurological and cognitive development of the offspring
timeFrame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
measure: weight development
timeFrame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
measure: height
timeFrame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
measure: life style and diet
timeFrame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years
measure: electroencephalography (EEG)
timeFrame: age 8 years and 9.5 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University
city: Pecs
country: Hungary
facility: University of Pecs
city: Granada
country: Spain
facility: Department of Paediatrics, University of Granada
Study officials:
affiliation: Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich
name: Berthold Koletzko, Prof.
role: STUDY_DIRECTOR
References:
citation: Krauss-Etschmann S, Shadid R, Campoy C, Hoster E, Demmelmair H, Jimenez M, Gil A, Rivero M, Veszpremi B, Decsi T, Koletzko BV; Nutrition and Health Lifestyle (NUHEAL) Study Group. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr. 2007 May;85(5):1392-400. doi: 10.1093/ajcn/85.5.1392.
citation: Catena A, Munoz-Machicao JA, Torres-Espinola FJ, Martinez-Zaldivar C, Diaz-Piedra C, Gil A, Haile G, Gyorei E, Molloy AM, Decsi T, Koletzko B, Campoy C. Folate and long-chain polyunsaturated fatty acid supplementation during pregnancy has long-term effects on the attention system of 8.5-y-old offspring: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):115-27. doi: 10.3945/ajcn.115.109108. Epub 2015 Nov 11.
citation: Campoy C, Escolano-Margarit MV, Ramos R, Parrilla-Roure M, Csabi G, Beyer J, Ramirez-Tortosa MC, Molloy AM, Decsi T, Koletzko BV. Effects of prenatal fish-oil and 5-methyltetrahydrofolate supplementation on cognitive development of children at 6.5 y of age. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1880S-1888S. doi: 10.3945/ajcn.110.001107. Epub 2011 Aug 17.
citation: Escolano-Margarit MV, Ramos R, Beyer J, Csabi G, Parrilla-Roure M, Cruz F, Perez-Garcia M, Hadders-Algra M, Gil A, Decsi T, Koletzko BV, Campoy C. Prenatal DHA status and neurological outcome in children at age 5.5 years are positively associated. J Nutr. 2011 Jun;141(6):1216-23. doi: 10.3945/jn.110.129635. Epub 2011 Apr 27.