Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women

Study Overview
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Brief Summary
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Iron deficiency is common in Switzerland and the main reason for anaemia. Nearly one in five premenopausal women suffers from iron deficiency. Low iron intake, reduced iron resorption or loss of blood are the main cause for iron deficiency. Symptoms of iron deficiency, for example fatigue, weakness, headache or exercise intolerance are primarily due to anaemia, but the same symptoms may also be present in non-anaemic patients with low serum ferritin. Consequently it is important to detect and treat non-anaemic iron deficiency. Common side effects of oral iron supplementation are primarily gastrointestinal symptoms like nausea, vomiting, diarrhea or abdominal pain. There is a positive correlation between appearance of gastrointestinal symptoms and administered iron dose. To date, only few studies have investigated effectiveness of low-dose iron supplementation in different target groups. The aim of this study is to investigate if low dose iron supplementation with 12mg iron per day for 8 weeks is sufficient to increase serum ferritin levels into a normal range in healthy premenopausal women suffering from non-anaemic iron deficiency

Official Title
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Single Center Clinical Trial to Evaluate the Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women

Conditions
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Iron Deficiency (Without Anemia)

Intervention / Treatment
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* Dietary Supplement: Eisen


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 <30ng/ml No anaemia symptomatic iron deficiency in the past No intake of dietary supplements Exclusion Criteria Intake of dietary supplements Pregnancy Hypermenorrhea Anaemia Serum-ferritin >30ng/ml BMI <18 kg/m² or >25 kg/m² chronic inflammatory diseases (e.g. colitis) Hypersensitivity to iron-supplements psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron-treatment group<br> | Dietary Supplement: Eisen<br>* Treatment with low-dose iron in the form of tablets containing 6mg of iron. Treatment consists of twice-daily oral administration of iron-tablets for 8 weeks in total.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of serum ferritin concentration under iron supplementation | significant increase of serum-ferritin concentration after 8 weeks of low-dose iron-supplementation | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side-effects of treatment | Adverse events will be assessed on a report form after 8 weeks | 8 weeks | 
| Serum hepcidin concentration | no increase in hepcidin-production during low-dose iron supplementation | 8 weeks |