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Iron Metabolism DisordersNCT03317873

The Effect of Genetic Variation in TMPRSS6 Gene (SNP rs855791) on Oral Iron Absorption: an Iron Stable Isotope Study

A study testing Testmeal A and Testmeal B in people with Iron Metabolism Disorders, run by Swiss Federal Institute of Technology at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 molecule of iron metabolism is hepcidin, a hormone produced in the liver that regulates intestinal iron absorption, placental… Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Iron Metabolism Disorders
What is being tested?
Testmeal A and Testmeal B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTaiwan
Study dates
1 Nov 2017to 19 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung-Chang Gun Memorial Hospital

    Kaohsiung City, Kaohsiung, 83301

Other trials in Taiwan

About this study

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 molecule of iron metabolism is hepcidin, a hormone produced in the liver that regulates intestinal iron absorption, placental transport, recycling of iron by macrophages and release from stores. The expression of hepcidin is regulated by many mediators, one of which is Matriptase-2 - a transmembrane protease. Complete loss of function leads to the rare disease iron-refractory iron deficiency anemia (IRIDA). Matriptase-2 is encoded by the gene TMPRSS6 and the single nucleotide polymorphism (SNP) rs855791 causes a non-synonymous substitution (V736A) that reduces the activity of the protease to inhibit hepcidin transcription. Genome wide association studies have identified the TMPRSS6 SNP rs855791 has a strong association with red blood cell and iron parameters in the general population.

The objectives of the study is to measure oral iron absorption and systemic iron utilization into red blood cells (RBC) using oral isotopic labels in subjects homozygotes for common variants of the TMPRSS6 gene with the SNP rs855791 (A736V); AA vs. VV subjects.

The aim is to conduct an iron absorption study in 80 Taiwanese women of reproductive age, non-pregnant, non-anemic, investigating the effect of the genetic variants of the SNP rs855791. The participants will be split in two groups of equal size; wild type AA vs. mutation VV. Iron absorption and systemic utilization will be assessed by two test meals containing stable isotopes of iron.The primary outcome of the trial is the oral iron absorption from a test meal as compared between the two genotypes AA vs. VV. Secondary outcomes are the comparison iron status markers between the two genotypes.

Being tested
Testmeal A, Testmeal B
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.

  • Testmeal ADietary supplement

    The tesmeal A is is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate

  • Testmeal BDietary supplement

    The tesmeal B is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate

Study groups in NCT03317873
Study groupRoleWhat they receive
wild type AA (CC)ExperimentalAll participants with the wild type genotype AA (CC) will be allocated to this group
Receives: Dietary Supplement: Testmeal A; Dietary Supplement: Testmeal B
mutation VV (TT)ExperimentalAll participants with the mutation genotype VV (TT) will be allocated to this group
Receives: Dietary Supplement: Testmeal A; Dietary Supplement: Testmeal B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the isotopic ratio of iron in blood at week 2

    The change in the isotopic ratio of iron in blood will be measured after the administration of test meal including iron isotopes.

    Measured: baseline, 2 weeks

Secondary outcomes (2)

  1. hepcidin

    fasting concentrations of plasma hepcidin in AA and VV variants of SNP rs855791

    Measured: baseline

  2. iron status

    The difference in fasting concentrations of serum iron, transferrin saturation, serum ferritin, hemoglobin, erythrocyte volume in AA and VV variants of SNP rs855791

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start1 Nov 2017
  3. Primary completion19 Feb 2019
  4. Study completion19 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317873
Sponsor's protocol ID
TMPRSS6_Fe
Status last verified
Jun 2019
First submitted
18 Oct 2017
Last updated
12 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Buerkli S, Pei SN, Hsiao SC, Lee CT, Zeder C, Zimmermann MB, Moretti D. The <em>TMPRSS6</em> variant (SNP rs855791) affects iron metabolism and oral iron absorption - a stable iron isotope study in Taiwanese women. Haematologica. 2021 Nov 1;106(11):2897-2905. doi: 10.3324/haematol.2020.264556.

    PubMed 33054130

Questions about this trial

What is this clinical trial studying?

A study testing Testmeal A and Testmeal B in people with Iron Metabolism Disorders, run by Swiss Federal Institute of Technology at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the isotopic ratio of iron in blood at week 2 (time frame: baseline, 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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