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NCT04636060 Clinical Trial

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

Iron Deficiency (Without Anemia) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04636060
Other study ID # LowdoseIron
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date November 15, 2021

Study information
Verified date January 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date November 15, 2021
Est. primary completion date November 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Eisen
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.

Locations
Country Name City State
Switzerland Universitätsspital Zürich Zürich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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