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

NCT ID: NCT04636060

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Deficiency (Without Anemia)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iron-treatment group

Group Type EXPERIMENTAL

Eisen

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pierre-Alexandre Krayenbuehl

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pierre-Alexandre Krayenbühl

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsspital Zürich

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Simic S, Karczewski M, Klapdor S, Nowak A, Schubert M, Moretti D, Swinkels DW, Beuschlein F, Saleh L, Suter P, Krayenbuehl PA. Effectiveness of low-dose iron treatment in non-anaemic iron-deficient women: a prospective open-label single-arm trial. Swiss Med Wkly. 2023 May 25;153:40079. doi: 10.57187/smw.2023.40079.

Reference Type DERIVED
PMID: 37229775 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LowdoseIron

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Iron Substitution in Blood Donors
NCT01519830 COMPLETED PHASE4
Hepcidin After Intravenous Iron Treatment
NCT06264687 NOT_YET_RECRUITING