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

January 16, 2022 updated by: Pierre-Alexandre Krayenbuehl, University of Zurich

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • UniversitätsSpital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron-treatment group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of serum ferritin concentration under iron supplementation
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Adverse events will be assessed on a report form after 8 weeks
8 weeks
Serum hepcidin concentration
Time Frame: 8 weeks
no increase in hepcidin-production during low-dose iron supplementation
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Pierre-Alexandre Krayenbühl, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

November 15, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 14, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 16, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LowdoseIron

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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