Iron Deficiency (Without Anemia)
Conditions
Keywords
iron deficiency, low dose iron therapy, iron therapy
Brief summary
The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.
Detailed description
The established therapy for iron-deficiency today is oral iron supplementation. However, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. There are some studies that have compared the efficacy of low-dose iron with normal-dose iron. These showed that the side effects are dose-dependent. Furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. In a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. Therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. Additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 2 months (60 days), the other one will get two placebo tablet for 2 months, accordingly.
Interventions
DIETARY_SUPPLEMENTIron
60 ± 5 days of daily oral iron supplementation.
OTHERPlacebo
60 ± 5 days of daily oral placebo intake.
Sponsors
Dr. Krayenbühl GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
study employees
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* informed consent as documented by signature * female gender * premenopausal * age \> 18 years * regular menstrual cycle * BMI in normal range (18-25 kg/m²) * serum-ferritin ≤30µg/l * no anaemia (Hemoglobin ≥117g/l) * no intake of dietary supplements containing iron (last 4 weeks) * the participant is linguistically and cognitively able to understand the study procedure
Exclusion criteria
* Current pregnancy * breastfeeding * hypermenorrhea (more than 5 unties/tampons per day) * chronic inflammatory diseases (e.g. colitis) * psychiatric disorders * chronic kidney disease (creatinine \>80 µmol/l) * liver disease (ALT \>35 U/l) * increased CRP (\>5mg/l) * hypersensitivity to iron-supplements * intake of medicines that interact with oral iron supplementation (e.g. PPI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum-ferritin change | 60 ± 5 days | significant change of serum-ferritin under supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 60 ± 5 days | change of blood pressure (systolic and diastolic blood pressure) |
| Blood Sugar | 60 ± 5 days | change of blood sugar levels |
| Lipid Status | 60 ± 5 days | change of lipid status (total cholesterol, HDL, LDL, triglycerides) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | 60 ± 5 days | Incidence of adverse events during 2 months under low dose iron supplementation and placebo treatment. |
Countries
Switzerland
Outcome results
None listed