Genetic Variants and Iron Absorption

NCT02197624 | Completed

• 1 other identifier: IRB #: 1206003117
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian women. The investigators hypothesize that the genetic variant could enhance iron status and iron absorption in Asian women.

Conditions

Iron Absorption

Keywords

Non-heme iron absorption; HFE

Outcome Measures

Primary Outcomes (5)

• Genotype at SNP rs9366637

  At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining genotype.

  2 weeks after the participant's visit to the laboratory

• Hemoglobin

  At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of hemoglobin.

  Up to 2 days after the participant's visit to the laboratory

• Serum Ferritin

  At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum ferritin.

  Up to 6 months after the participant's visit to the laboratory

• Serum transferrin receptor

  At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum transferrin receptor.

  Up to 6 months after the participant's visit to the laboratory

• Non-heme Iron absorption in women with 2 HFE genotypes

  Women donated a blood sample for genotyping. Women with particular HFE genotypes were invited to return for an absorption study. Two weeks after women consume the iron tracer, a blood sample was obtained to measure the amount of iron absorbed.

  one month for screening with genotype then 2 weeks for iron absorption study

Secondary Outcomes (3)

• Folate

  Up to 6 months after the participant's visit to the laboratory

• Vitamin B-12

  Up to 6 months after the participant's visit to the laboratory

• C-reactive protein

  Up to 6 months after the participant's visit to the laboratory

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women were eligible for the study if they met the following criteria: 1) non-pregnant and between the ages of 18\~35 y; 2) of East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore; 3) not taking any vitamin or mineral supplements for at least 1 month before the study and during the 2-week study interval; 4) no pre-existing medical problems including malabsorption, blood disorders, ulcers, joint diseases or asthma that might impact inflammation or Fe status; 5) not taking any prescribed medications known to affect iron homeostasis.

You may qualify if:

• non-pregnant and between the ages of 18\~35 y
• East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore

You may not qualify if:

• taking or planing to take any vitamin or mineral supplements during the study period
• pre-existing medical problems that might impact inflammation or Fe status, including malabsorption, blood disorders, ulcers, joint diseases and asthma
• taking any prescribed medications known to affect iron homeostasis

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two 10 mL blood samples and one 3 mL blood sample were collected.

Study Officials

• Kimberly O'Brien, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 23, 2014
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

US (1)