Clinical trial NCT04735848: Plasma Hepcidin Response to Differently Dosed Iron Supplements
Official title: Single Center Clinical Trial to Evaluate the Effect of Different Amounts of Iron Supplements on the Plasma Hepcidin Level in Non-anemic Iron-deficient Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency (Without Anemia)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The participants will take all three different doses of iron and will serve as there own control
Primary purpose: BASIC_SCIENCE

Brief summary: The study participants will take 3 different doses of iron supplements at 8 am, on 3 different days. By taking blood samples in the morning and afternoon, the investigators will determine the effects of the iron supplements on plasma hepcidin and compare them to baseline plasma hepcidin values.

Detailed description: 15 healthy young women with non-anemic iron deficiency will participate in the study. On 4 different days the investigators will take two blood samples (one in the morning at 8 am, before the iron intake and one in the afternoon at 4 pm) to determine the plasma hepcidin level. The intake of the iron supplements will be at least 48 hours apart from each other, to exclude any impacts of the previous iron intake to the next measurement.

The participants will take the iron supplement supervised at 8 am after overnight fasting.

All blood samples will be performed for analysis of CRP and hepcidin. The investigators will measure the CRP in the blood sample to exclude any impacts of inflammation to the hepcidin measurement and use a CRP ≤5mg/l as a cut-off. If the CRP is higher than 5mg/l the investigators will exclude the measurement from our analyses and repeat the measurement at another day.

The first two blood samples will be taken at 8 am and at 4 pm on the same day and after overnight fasting to find the baseline hepcidin, the other blood samples will be taken at 8 am before the iron intake and at 4 pm also on the same day and also after overnight fasting.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Female gender
* Premenopausal
* Age \> 18 years
* Regular menstrual cycle
* BMI in normal range (18-25kg/m2)
* Serum-ferritin ≤30ng/ml
* No anemia
* No intake of dietary supplements

Exclusion Criteria:

* Intake of dietary supplements
* Pregnancy
* Hypermenorrhea (\> 80ml blood loss, or more than 5 unties/tampons per day)
* Anemia
* Serum-ferritin \>30ng/ml
* BMI \<18 kg/m2 or \>25 kg/m2
* Chronic inflammatory disease
* Hypersensitivity to iron supplements

Primary outcomes:
measure: Plasma hepcidin change
timeFrame: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.
Secondary outcomes:
measure: Dose-response relationship between iron and hepcidin
timeFrame: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.
Other outcomes:
measure: Number of participants with side effects
timeFrame: The participants will be asked for side effects in the afternoon of the same day as the participants take the iron-supplement. The analysis of the reported side-effects is planed to be done up to 6 month from the first baseline visit.
Locations:
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: University of Zurich
name: Pierre-Alexandre Krayenbühl
role: PRINCIPAL_INVESTIGATOR
References: