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

Not Applicable

Completed

• Conditions: Iron Deficiency (Without Anemia)
• Interventions: Dietary Supplement: Eisen

• Registration Number: NCT04636060
• Lead Sponsor: University of Zurich

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-14
• Study First Posted: 2020-11-19
• Study Start: 2021-07-01
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-16
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron-treatment group	Eisen	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland