Fish Oil and Folate Supplementation During Pregnancy - Full Text View

Purpose

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.

Condition	Intervention
Perinatal DHA and Folate Status Neurological Development	Dietary Supplement: fish oil Dietary Supplement: folate Dietary Supplement: fish oil + folate Dietary Supplement: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy

Resource links provided by NLM:

MedlinePlus related topics: Allergy B Vitamins Dietary Supplements Minerals

Drug Information available for: Folic acid Fish oil Vitamin B Complex Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood [ Time Frame: at the time of birth ] [ Designated as safety issue: No ]
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 Outcome Measures:

neurological and cognitive development of the offspring [ Time Frame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years ] [ Designated as safety issue: No ]
non invasive, age adequate, tests of neurological and cognitive function are performed at various ages of the offspring
weight development [ Time Frame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years ] [ Designated as safety issue: No ]
body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined
height [ Time Frame: age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years ] [ Designated as safety issue: No ]
body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
life style and diet [ Time Frame: age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years ] [ Designated as safety issue: No ]
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) [ Time Frame: age 8 years and 9.5 years ] [ Designated as safety issue: No ]
at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests

Enrollment:	315
Study Start Date:	November 2001
Estimated Study Completion Date:	March 2013
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Dietary Supplement: fish oil 400 mg of DHA and 150 mg of eicosapentaenoic acid per day
Experimental: 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	Dietary Supplement: folate 400 µg per day
Experimental: 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	Dietary Supplement: fish oil + folate 500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
Placebo Comparator: placebo 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 only vitamins and minerals as recommended, but no fish oil or folate

Eligibility

Ages Eligible for Study:	18 Years to 41 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180933

Locations

Germany
Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University
Munich, Germany, 80337
Hungary
University of Pecs
Pecs, Hungary, 7623
Spain
Department of Paediatrics, University of Granada
Granada, Spain, 18012

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

European Union

Investigators

Study Director:

Berthold Koletzko, Prof.

Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich

More Information

Publications:

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 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Campoy C, Escolano-Margarit MV, Ramos R, Parrilla-Roure M, Csábi 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. Epub 2011 Aug 17.

Escolano-Margarit MV, Ramos R, Beyer J, Csábi 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. Epub 2011 Apr 27.

Responsible Party:	Prof. Dr. Berthold Koletzko, Ludwig-Maximilians University of Munich
ClinicalTrials.gov Identifier:	NCT01180933 History of Changes
Other Study ID Numbers:	01111
Study First Received:	August 11, 2010
Last Updated:	December 13, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:

docosahexaenoic acid
folate
neurological development

allergies
long term consequences for the offspring
allergy risk

Additional relevant MeSH terms:

Folic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

Fish Oil and Folate Supplementation During Pregnancy (NUHEAL)