Fish Oil and Folate Supplementation During Pregnancy

Not Applicable

Completed

• Conditions: Neurological Development; Perinatal DHA and Folate Status

• Registration Number: NCT01180933
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2003-08
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Study Completion: 2013-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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
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
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

Trial Locations

Locations (3)

Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University; 🇩🇪 Munich, Germany

University of Pecs; 🇭🇺 Pecs, Hungary

Department of Paediatrics, University of Granada; 🇪🇸 Granada, Spain