Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

Study Overview
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Brief Summary
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The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.

Detailed Description
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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 3 months (90 days), the other one will get two placebo tablet for 3 months, accordingly.

Official Title
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Randomised, Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

Conditions
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Iron Deficiency (Without Anemia)

Intervention / Treatment
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* Dietary Supplement: Iron
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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) Hypo- or Hyperthyroidism (TSH not between 0.16 - 4.25 mU/l) hypersensitivity to iron-supplements intake of medicines that interact with oral iron supplementation (e.g. PPI)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo tablet containing no iron | Other: Placebo<br>* 90 ± 5 days of daily oral placebo intake.<br>|
| Experimental: Low Dose Iron<br>low-dose tablet containing 6mg of iron | Dietary Supplement: Iron<br>* 90 ± 5 days of daily oral iron supplementation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum-ferritin change | significant change of serum-ferritin under supplementation | 90 ± 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | change of blood pressure (systolic and diastolic blood pressure) | 90 ± 5 days | 
| Blood Sugar | change of blood sugar levels | 90 ± 5 days | 
| Lipid Status | change of lipid status (total cholesterol, HDL, LDL, triglycerides) | 90 ± 5 days |