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Fish Oil and Folate Supplementation During Pregnancy (NUHEAL)

29. juli 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

315

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Granada, Spanien, 18012
        • Department of Paediatrics, University of Granada
  • Tyskland
      • Munich, Tyskland, 80337
        • Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University
  • Ungarn
      • Pecs, Ungarn, 7623
        • University of Pecs

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 41 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Kosttilskud: fish oil
400 mg of DHA and 150 mg of eicosapentaenoic acid per day
Eksperimentel: 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
Kosttilskud: folate
400 µg per day
Eksperimentel: 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
Kosttilskud: fish oil + folate
500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
Placebo komparator: placebo
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery
Kosttilskud: placebo
only vitamins and minerals as recommended, but no fish oil or folate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
neurological and cognitive development of the offspring
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ludwig-Maximilians - University of Munich

Samarbejdspartnere

European Union

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2001

Primær færdiggørelse (Faktiske)

1. august 2003

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

11. august 2010

Først indsendt, der opfyldte QC-kriterier

11. august 2010

Først opslået (Skøn)

12. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 01111

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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