NCT03276247

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22,042

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

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

January 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

September 1, 2017

Last Update Submit

September 7, 2017

Conditions

Iron Metabolism Disorders

Outcome Measures

Primary Outcomes (3)

  • Elevated serum ferritin

    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

    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

    Serum ferritin \<15ug/L

    One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

Study Arms (8)

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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: observation

Interventions

observationOTHER

observation

African American non-pregnantAfrican American pregnantAsian American non-pregnantAsian American pregnantHispanic American non-pregnantHispanic American pregnantWhite non-pregnantWhite pregnant

Eligibility Criteria

Age25 Years - 44 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primary care women included in the HEIRS study.

You may qualify if:

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

You may not qualify if:

  • Age \>44 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Gordeuk VR, Brannon PM. Ethnic and genetic factors of iron status in women of reproductive age. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1594S-1599S. doi: 10.3945/ajcn.117.155853. Epub 2017 Oct 25.

    PMID: 29070555DERIVED

MeSH Terms

Conditions

Iron Metabolism Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Victor R Gordeuk, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 8, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 8, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)