Iron Deficiency (Without Anemia)
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTIron-supplement application
The participants will take the corresponding amount of iron-supplement supervised at 8am.
Sponsors
Pierre-Alexandre Krayenbuehl
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The participants will take all three different doses of iron and will serve as there own control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma hepcidin change | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Switzerland
Outcome results
None listed