Iron Metabolism DisordersNCT03276247
Iron Status in Women of Reproductive Age Reproductive Age
An observational study of Iron Metabolism Disorders, run by Victor Gordeuk at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 44 years, women only
- Conditions the study is for
- Iron Metabolism Disorders
- What is being tested?
- observation
- How many people
- 22,042 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 1 Aug 2017
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 44 years
- Women only
- Adult
Study population: Primary care women included in the HEIRS study.
Who may be able to join
- 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.
Who cannot join
- Age >44 years
- Self-described ethnicity other in than inclusion criterion 2.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Iron Metabolism Disorders
- Being tested
- observation
- Medical subject headings
- Iron Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated serum ferritin
Serum ferritin >300 ug/L
Measured: 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%
Measured: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Iron deficiency
Serum ferritin <15ug/L
Measured: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Jan 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Gordeuk
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor-investigator, Victor Gordeuk, University of Illinois at Chicago
- Investigators
- Victor R Gordeuk, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276247
- Sponsor's protocol ID
- HEIRS-womenrepage
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29070555