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Iron Status in Women of Reproductive Age Reproductive Age

7. september 2017 opdateret af: Victor Gordeuk

Ethnic and Genetic Factors of Iron Status in Women of Reproductive Age

Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in the United States and Canada using de-identified data from the HEIRS study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

HEIRS included a cross-sectional screening study of 101,168 patients, 25 years of age or older, in the primary care setting. Participants were recruited from four centers in the U.S .and one in Canada from February 2001 to February 2003. We will evaluate results for women aged 25-44 years of age who are self-reported as Asian, Black, Hispanic or White. The lower detection limit for the serum ferritin (SF) assay in the HEIRS study was 15 μg/L and therefore the definition of iron deficiency will be SF concentration ≤ 15 μg/L. Elevated SF concentrations, possibly indicative of elevated iron stores, will be classified by two definitions: 1) SF concentration > 300 μg/L and 2) SF >200 μg/L in combination with TSAT >45%. Proportions will be compared by Pearson's chi-square. Logistic regression models will be used to identify independent associations with measures of iron deficiency and elevated iron stores.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

22042

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago

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

25 år til 44 år (Voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Primary care women included in the HEIRS study.

Beskrivelse

Inclusion Criteria:

  1. primary care women included in the HEIRS study with in the age range of this study
  2. Self designation as Asian American, African American, Hispanic American or White.

Exclusion Criteria:

  1. Age >44 years
  2. Self-described ethnicity other in than inclusion criterion 2.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Asian American non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and non-pregnant/non-breastfeeding.
Andet: observation
observation
African American non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and non-pregnant/non-breastfeeding.
Andet: observation
observation
Hispanic American non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and non-pregnant/non-breastfeeding.
Andet: observation
observation
White non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as white and non-pregnant/non-breastfeeding.
Andet: observation
observation
Asian American pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and pregnant or breastfeeding.
Andet: observation
observation
African American pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and pregnant or breastfeeding.
Andet: observation
observation
Hispanic American pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and pregnant or breastfeeding.
Andet: observation
observation
White pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as White and pregnant or breastfeeding.
Andet: observation
observation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Elevated serum ferritin
Tidsramme: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Serum ferritin >300 ug/L
One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Elevated serum ferritin and transferrin saturation
Tidsramme: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Serum ferritin >200 ug/L and transferrin saturation >45%
One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Iron deficiency
Tidsramme: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Serum ferritin <15ug/L
One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

Samarbejdspartnere og efterforskere

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

Sponsor

Victor Gordeuk

Samarbejdspartnere

Weill Medical College of Cornell University

Efterforskere

  • Ledende efterforsker: Victor R Gordeuk, MD, University of Illinois at Chicago

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 (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

1. august 2017

Studieafslutning (Faktiske)

1. august 2017

Datoer for studieregistrering

Først indsendt

1. september 2017

Først indsendt, der opfyldte QC-kriterier

7. september 2017

Først opslået (Faktiske)

8. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HEIRS-womenrepage

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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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