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Completed

NCT Number: NCT04735848

Plasma Hepcidin Response to Differently Dosed Iron Supplements

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.

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Key information

Conditions

Iron Deficiency (Without Anemia) Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsspital Zürich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron-supplement application

Dietary Supplement

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

Primary outcomes

  1. Plasma hepcidin change

    Time frame: 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.

    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.

Secondary outcomes

  1. Dose-response relationship between iron and hepcidin

    Time frame: 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.

    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.

Other outcomes

  1. Number of participants with side effects

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Pierre-Alexandre Krayenbuehl

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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