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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency (Without Anemia)

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