An interventional study of Testmeal A and Testmeal B in Iron Metabolism Disorders, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Prevention
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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.
21 studies on the registry are indexed under Iron Metabolism Disorders; 7 are open to participants now.
This study's enrollment of 80 is above the median of 31 across 14 interventional studies indexed under Iron Metabolism Disorders.
Browse Iron Metabolism Disorders studies →Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants with the wild type genotype AA (CC) will be allocated to this group
Dietary Supplement: Testmeal A · Dietary Supplement: Testmeal B
All participants with the mutation genotype VV (TT) will be allocated to this group
Dietary Supplement: Testmeal A · Dietary Supplement: Testmeal B
The tesmeal A is is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate
The tesmeal B is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate
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.
Time frame: baseline, 2 weeks
hepcidin
fasting concentrations of plasma hepcidin in AA and VV variants of SNP rs855791
Time frame: baseline
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
Time frame: baseline
Ran from Nov 2017 to primary completion in Feb 2019, 15 months.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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