Status:
COMPLETED
The Effect of Genetic Variation in TMPRSS6 Gene (SNP rs855791) on Oral Iron Absorption: an Iron Stable Isotope Study
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Chang Gung Memorial Hospital
Conditions:
Iron Metabolism Disorders
Eligibility:
FEMALE
20-45 years
Phase:
NA
Brief Summary
Iron deficiency is considered the most common nutritional deficiency worldwide and affects children and women in both non-industrialized as well as industrialized countries. The main regulatory molecu...
Eligibility Criteria
Inclusion
- Subjects homozygotous for the for AA (CC), or VV (TT) variant of the SNP rs855791 of the TMPRSS6 gene.
- Females 20 - 45 years of age (premenopausal status)
- obtained informed consent
- regular menstrual cycle, ± 2 days
Exclusion
- Pregnancy or lactating (assessed by pregnancy test and self-declaration, respectively)
- Anemia defined as Hb \< 120 g/L
- Plasma ferritin \< 30 µg/l, or \> 120 µg/l
- C-reactive Protein \> 5 mg/l
- Body weight \> 65 kg
- Body mass index (BMI) 18.5 - 25
- Diagnosed metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal.
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months, prior the first study day.
- Subjects who cannot be expected to comply with study protocol (e.g. non-residents).
- Use of long-term medication during the study
- Subjects that will take part of another clinical study at the same time or had within the last 30 days before the first study day
- Intake of mineral/vitamin supplements 2 weeks before the first study day and during the study
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03317873
Start Date
November 1 2017
End Date
February 19 2019
Last Update
June 12 2019
Active Locations (1)
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1
Kaohsiung-Chang Gun Memorial Hospital
Kaohsiung City, Kaohsiung, Taiwan, 83301