Fish Oil and Folate Supplementation During Pregnancy (NUHEAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Union
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01180933
First received: August 11, 2010
Last updated: December 13, 2012
Last verified: December 2012
  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:


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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 23, 2014