Plasma Hepcidin Response to Differently Dosed Iron Supplements

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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency (Without Anemia)
• Intervention / Treatment: Dietary supplement: Iron-supplement application

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6mg iron-supplement; 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; The participants will take the corresponding amount of iron-supplement supervised at 8am.
Experimental: 30mg iron-supplement; 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; The participants will take the corresponding amount of iron-supplement supervised at 8am.
Experimental: 60mg iron-supplement; 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; The participants will take the corresponding amount of iron-supplement supervised at 8am.
No Intervention: Baseline; Baseline measurement

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with side effects	The investigators will analyze number the side effects named as nausea, abdominal pain or constipation, which occurred on the day of the iron-intake and were reported at the interview in the afternoon. The investigators will compare the amount of side-effects that occurred in each dosage group. The investigators expect a dose-dependent occurrence.	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.

Collaborators and Investigators

• Sponsor: Pierre-Alexandre Krayenbuehl
• Investigators: Principal Investigator: Pierre-Alexandre Krayenbühl, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: Plasma hepcidin response

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No