Iron Deficiency (Without Anemia)NCT04636060
Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women
A study testing Eisen in people with Iron Deficiency (Without Anemia), run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- Eisen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2021to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Female gender
- Premenopausal
- Age > 18 years
- Regular menstrual cycle
- BMI in normal range (18-25 kg/m²)
Show all 10Show fewer
- Serum-ferritin <30ng/ml
- No anaemia
- symptomatic iron deficiency in the past
- No intake of dietary supplements
Who cannot join
- Intake of dietary supplements
- Pregnancy
- Hypermenorrhea
- Anaemia
- Serum-ferritin >30ng/ml
- BMI <18 kg/m² or >25 kg/m²
Show all 9Show fewer
- chronic inflammatory diseases (e.g. colitis)
- Hypersensitivity to iron-supplements
- psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Eisen
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EisenDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Iron-treatment group | Experimental | Not described Receives: Dietary Supplement: Eisen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of serum ferritin concentration under iron supplementation
significant increase of serum-ferritin concentration after 8 weeks of low-dose iron-supplementation
Measured: 8 weeks
Secondary outcomes (2)
Side-effects of treatment
Adverse events will be assessed on a report form after 8 weeks
Measured: 8 weeks
Serum hepcidin concentration
no increase in hepcidin-production during low-dose iron supplementation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jul 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency (Without Anemia)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre-Alexandre Krayenbuehl, University of Zurich
- Investigators
- Pierre-Alexandre Krayenbühl, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636060
- Sponsor's protocol ID
- LowdoseIron
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37229775
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Clinical Trial to Evaluate the Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women
- ClinicalTrials.gov ID
- NCT04636060
- Acronym / sponsor ID
- LowdoseIron
- Conditions
- Iron Deficiency (Without Anemia)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron-treatment group | Experimental | Dietary Supplement: Eisen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed Consent as documented by signature
- Female gender
- Premenopausal
- Age > 18 years
- Regular menstrual cycle
Key exclusion criteria (9 listed)
- Intake of dietary supplements
- Pregnancy
- Hypermenorrhea
- Anaemia
- Serum-ferritin >30ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EisenTreatment 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. | Dietary supplement | Iron-treatment group |
Primary outcome
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
2 secondary outcomes
Side-effects of treatment
Time frame: 8 weeks
Serum hepcidin concentration
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 37229775Simic 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.
Related trials for Iron Deficiency (Without Anemia)
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
Not yet recruitingObservational study
Impact of Iron Deficiency on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure
Heart Failure, Iron Deficiency
Recruiting
Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)
Non-Anemic Iron Deficiency
Active, not recruiting
The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females
Anemia, Iron Deficiency (Without Anemia)
RecruitingObservational study
Non-invasive Detection of Iron Deficiency in Obstetrics
Iron Deficiency Anemia of Pregnancy, Iron-deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Alexandre Krayenbühl principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eisen in people with Iron Deficiency (Without Anemia), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of serum ferritin concentration under iron supplementation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.