Plasma Hepcidin Response to Differently Dosed Iron Supplements

Pierre-Alexandre Krayenbuehl

Status: Completed

Conditions: Iron Deficiency (Without Anemia)

Treatments: Dietary Supplement: Iron-supplement application

Study type: Interventional

Funder types: Other

Identifiers

NCT04735848

Plasma hepcidin response

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

15 participants in 4 patient groups

6mg iron-supplement

Experimental group

Description:

All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg).

Treatment:

Dietary Supplement: Iron-supplement application

30mg iron-supplement

Experimental group

Description:

All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg).

Treatment:

Dietary Supplement: Iron-supplement application

60mg iron-supplement

Experimental group

Description:

All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg).

Treatment:

Dietary Supplement: Iron-supplement application

Baseline

No Intervention group

Description:

Baseline measurement