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Completed

NCT Number: NCT01180933

Fish Oil and Folate Supplementation During Pregnancy

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.

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Key information

Conditions

Perinatal DHA and Folate Status Hypersensitivity Immune System Diseases Neurological Development

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

400 mg of DHA and 150 mg of eicosapentaenoic acid per day

Folate

Dietary Supplement

400 µg per day

fish oil + folate

Dietary Supplement

500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day

Placebo

Dietary Supplement

only vitamins and minerals as recommended, but no fish oil or folate

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • European Union

Registry information

Official study title

Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy

Acronym: NUHEAL

Important dates

Study start
2001
Primary completion
2003
Study completion
2013
First posted
Aug 12, 2010
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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