Iron Deficiency (Without Anemia)
Conditions
Brief summary
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
Interventions
DIETARY_SUPPLEMENTEisen
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.
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 (18-25 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase of serum ferritin concentration under iron supplementation | 8 weeks | significant increase of serum-ferritin concentration after 8 weeks of low-dose iron-supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side-effects of treatment | 8 weeks | Adverse events will be assessed on a report form after 8 weeks |
| Serum hepcidin concentration | 8 weeks | no increase in hepcidin-production during low-dose iron supplementation |
Countries
Switzerland
Outcome results
None listed