Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
315 participants
INTERVENTIONAL
2001-11-30
2013-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
400 mg of DHA and 150 mg of eicosapentaenoic acid per day
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
folate
400 µg per day
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
fish oil + folate
500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
placebo
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery
placebo
only vitamins and minerals as recommended, but no fish oil or folate
Interventions
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fish oil
400 mg of DHA and 150 mg of eicosapentaenoic acid per day
folate
400 µg per day
fish oil + folate
500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
placebo
only vitamins and minerals as recommended, but no fish oil or folate
Eligibility Criteria
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Inclusion Criteria
* 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
* use fish oil supplements since the beginning of pregnancy
* use of folate or vitamin B-12 supplements after gestation week 16
18 Years
41 Years
FEMALE
Yes
Sponsors
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European Union
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Ludwig-Maximilians University of Munich
Principal Investigators
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Berthold Koletzko, Prof.
Role: STUDY_DIRECTOR
Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich
Locations
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Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University
Munich, , Germany
University of Pecs
Pécs, , Hungary
Department of Paediatrics, University of Granada
Granada, , Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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01111
Identifier Type: -
Identifier Source: org_study_id
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