Fish Oil and Folate Supplementation During Pregnancy (NUHEAL)

July 29, 2014 updated by: Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
Time Frame: 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
labour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
weight development
Time Frame: 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
age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
height
Time Frame: 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
age 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
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
electroencephalography (EEG)
Time Frame: 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
age 8 years and 9.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

European Union

Investigators

  • Study Director: Berthold Koletzko, Prof., Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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