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Fish Oil and Folate Supplementation During Pregnancy

NCT01180933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2014-07-30

No results posted yet for this study

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.

Conditions

  • Perinatal DHA and Folate Status
  • Neurological Development

Interventions

DIETARY_SUPPLEMENT

fish oil

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

DIETARY_SUPPLEMENT

folate

400 µg per day

DIETARY_SUPPLEMENT

fish oil + folate

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

DIETARY_SUPPLEMENT

placebo

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

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2003-08-31
Completion
2013-03-31

Countries

  • Germany
  • Hungary
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180933 on ClinicalTrials.gov