Plasma Hepcidin Response to Differently Dosed Iron Supplements

NCT04735848 | Completed DMC

• 1 other identifier: Plasma hepcidin response
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency (Without Anemia)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dose-response relationship between iron and hepcidin

  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 (1)

• Number of participants with side effects

  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.

Study Arms (4)

6mg iron-supplement

EXPERIMENTAL

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

30mg iron-supplement

EXPERIMENTAL

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

60mg iron-supplement

EXPERIMENTAL

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

Baseline

NO INTERVENTION

Baseline measurement

Interventions

Iron-supplement application DIETARY_SUPPLEMENT

The participants will take the corresponding amount of iron-supplement supervised at 8am.

30mg iron-supplement; 60mg iron-supplement; 6mg iron-supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre-Alexandre Krayenbuehl: lead

Study Sites (1)

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Karczewski M, Simic S, Saleh L, Nowak A, Schubert MG, Moretti D, Swinkels DW, Beuschlein F, Suter PM, Krayenbuehl PA. The magnitude of the plasma hepcidin response to oral iron supplements depends on the iron dosage. Swiss Med Wkly. 2024 Feb 19;154:3635. doi: 10.57187/s.3635.

  PMID: 38579297 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pierre-Alexandre Krayenbühl

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research associate at the Clinic for Endocrinology

Model Details: The participants will take all three different doses of iron and will serve as there own control

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 3, 2021
• Study Start: June 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

CH (1)