NCT01180933

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2001

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 30, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

August 11, 2010

Last Update Submit

July 29, 2014

Conditions

Perinatal DHA and Folate StatusNeurological Development

Keywords

docosahexaenoic acidfolateneurological developmentallergieslong term consequences for the offspringallergy risk

Outcome Measures

Primary Outcomes (1)

  • percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood

    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 Outcomes (5)

  • 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

  • weight development

    age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years

  • height

    age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years

  • life style and diet

    age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years

  • electroencephalography (EEG)

    age 8 years and 9.5 years

Study Arms (4)

fish oil

EXPERIMENTAL

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

folate

EXPERIMENTAL

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

fish oil + folate

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

fish oilDIETARY_SUPPLEMENT

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

fish oil
folateDIETARY_SUPPLEMENT

400 µg per day

folate
fish oil + folateDIETARY_SUPPLEMENT

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

fish oil + folate
placeboDIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Munich, 80337, Germany

Location

University of Pecs

Pécs, 7623, Hungary

Location

Department of Paediatrics, University of Granada

Granada, 18012, Spain

Location

Related Publications (4)

  • Krauss-Etschmann S, Shadid R, Campoy C, Hoster E, Demmelmair H, Jimenez M, Gil A, Rivero M, Veszpremi B, Decsi T, Koletzko BV; Nutrition and Health Lifestyle (NUHEAL) Study Group. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr. 2007 May;85(5):1392-400. doi: 10.1093/ajcn/85.5.1392.

    PMID: 17490978RESULT

  • Catena A, Munoz-Machicao JA, Torres-Espinola FJ, Martinez-Zaldivar C, Diaz-Piedra C, Gil A, Haile G, Gyorei E, Molloy AM, Decsi T, Koletzko B, Campoy C. Folate and long-chain polyunsaturated fatty acid supplementation during pregnancy has long-term effects on the attention system of 8.5-y-old offspring: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):115-27. doi: 10.3945/ajcn.115.109108. Epub 2015 Nov 11.

    PMID: 26561619DERIVED

  • Campoy C, Escolano-Margarit MV, Ramos R, Parrilla-Roure M, Csabi G, Beyer J, Ramirez-Tortosa MC, Molloy AM, Decsi T, Koletzko BV. Effects of prenatal fish-oil and 5-methyltetrahydrofolate supplementation on cognitive development of children at 6.5 y of age. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1880S-1888S. doi: 10.3945/ajcn.110.001107. Epub 2011 Aug 17.

    PMID: 21849596DERIVED

  • Escolano-Margarit MV, Ramos R, Beyer J, Csabi G, Parrilla-Roure M, Cruz F, Perez-Garcia M, Hadders-Algra M, Gil A, Decsi T, Koletzko BV, Campoy C. Prenatal DHA status and neurological outcome in children at age 5.5 years are positively associated. J Nutr. 2011 Jun;141(6):1216-23. doi: 10.3945/jn.110.129635. Epub 2011 Apr 27.

    PMID: 21525247DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

Fish OilsFolic Acid

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Berthold Koletzko, Prof.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 12, 2010

Study Start

November 1, 2001

Primary Completion

August 1, 2003

Study Completion

March 1, 2013

Last Updated

July 30, 2014

Record last verified: 2014-06

Locations

HU(1)ES(1)DE(1)