Plasma Hepcidin Response to Differently Dosed Iron Supplements

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Iron Deficiency (Without Anemia)

Intervention / Treatment
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* Dietary Supplement: Iron-supplement application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The participants will take all three different doses of iron and will serve as there own control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6mg iron-supplement<br>All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). | Dietary Supplement: Iron-supplement application<br>* The participants will take the corresponding amount of iron-supplement supervised at 8am.<br>|
| Experimental: 30mg iron-supplement<br>All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). | Dietary Supplement: Iron-supplement application<br>* The participants will take the corresponding amount of iron-supplement supervised at 8am.<br>|
| Experimental: 60mg iron-supplement<br>All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). | Dietary Supplement: Iron-supplement application<br>* The participants will take the corresponding amount of iron-supplement supervised at 8am.<br>|
| No Intervention: Baseline<br>Baseline measurement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma hepcidin change | The investigators will measure the plasma hepcidin level of the patients in the morning at 8am, (right before the intake of the iron-supplement) as well as in the afternoon at 4pm. The investigators will also measure the plasma hepcidin level on a baseline day (at the same times), when the patients don't take any iron supplement. By these measurements the investigators will report the change in the plasma hepcidin level after the intake of an iron-supplement. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response relationship between iron and hepcidin | In addition, the investigators will estimate a linear relationship (slope) between the iron dose and the plasma hepcidin level, using dose as a continuous explanatory factor in the model. The investigators will report a dose dependent assessment of the plasma hepcidin level. | 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. |