Iron Deficiency (Without Anemia)PCLDITNCT05869422
Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women
A study testing Iron in people with Iron Deficiency (Without Anemia), run by Dr. Krayenbühl GmbH at 1 site in Switzerland.
Trial summary
The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 May 2024to 21 Dec 2024
- 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 to 50 years
- Women only
- No healthy volunteers
- 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 ≤30µg/l
- no anaemia (Hemoglobin ≥117g/l)
- no intake of dietary supplements containing iron (last 4 weeks)
- the participant is linguistically and cognitively able to understand the study procedure
Who cannot join
- Current pregnancy
- breastfeeding
- hypermenorrhea (more than 5 unties/tampons per day)
- chronic inflammatory diseases (e.g. colitis)
- psychiatric disorders
- chronic kidney disease (creatinine >80 µmol/l)
Show all 10Show fewer
- liver disease (ALT >35 U/l)
- increased CRP (>5mg/l)
- hypersensitivity to iron-supplements
- intake of medicines that interact with oral iron supplementation (e.g. PPI)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Randomised, Double-blind, Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women
The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.
Read the detailed description
The established therapy for iron-deficiency today is oral iron supplementation. However, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. There are some studies that have compared the efficacy of low-dose iron with normal-dose iron. These showed that the side effects are dose-dependent. Furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. In a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. Therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. Additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 2 months (60 days), the other one will get two placebo tablet for 2 months, accordingly.
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Iron, Placebo
- Keywords
- iron deficiency, low dose iron therapy, iron therapy
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDietary supplement
60 ± 5 days of daily oral iron supplementation.
PlaceboOther
60 ± 5 days of daily oral placebo intake.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo tablet containing no iron Receives: Other: Placebo |
| Low Dose Iron | Experimental | low-dose tablet containing 6mg of iron Receives: Dietary Supplement: Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum-ferritin change
significant change of serum-ferritin under supplementation
Measured: 60 ± 5 days
Secondary outcomes (3)
Blood Pressure
change of blood pressure (systolic and diastolic blood pressure)
Measured: 60 ± 5 days
Blood Sugar
change of blood sugar levels
Measured: 60 ± 5 days
Lipid Status
change of lipid status (total cholesterol, HDL, LDL, triglycerides)
Measured: 60 ± 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start6 May 2024
- Primary completion21 Dec 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (Without Anemia)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Krayenbühl GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Albina Nowak, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869422
- Sponsor's protocol ID
- LowDoseIronVsPlacebo
- Other IDs
- SNCTP000005680
- Acronym
- PCLDIT
- Status last verified
- Jun 2025
- First submitted
- 11 May 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women
- ClinicalTrials.gov ID
- NCT05869422
- Acronym / sponsor ID
- PCLDIT / LowDoseIronVsPlacebo
- Conditions
- Iron Deficiency (Without Anemia)
- Keywords
- iron deficiency, low dose iron therapy, iron therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Dr. Krayenbühl GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 22 May 2023 (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.
The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.
Detailed description
The established therapy for iron-deficiency today is oral iron supplementation. However, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. There are some studies that have compared the efficacy of low-dose iron with normal-dose iron. These showed that the side effects are dose-dependent. Furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. In a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. Therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. Additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 2 months (60 days), the other one will get two placebo tablet for 2 months, accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placeboplacebo tablet containing no iron |
| Low Dose Iron | Experimental | Dietary Supplement: Ironlow-dose tablet containing 6mg of iron |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- informed consent as documented by signature
- female gender
- premenopausal
- age > 18 years
- regular menstrual cycle
Key exclusion criteria (10 listed)
- Current pregnancy
- breastfeeding
- hypermenorrhea (more than 5 unties/tampons per day)
- chronic inflammatory diseases (e.g. colitis)
- psychiatric disorders
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 |
|---|---|---|
| Iron60 ± 5 days of daily oral iron supplementation. | Dietary supplement | Low Dose Iron |
| Placebo60 ± 5 days of daily oral placebo intake. | Other | Placebo |
Primary outcome
Serum-ferritin change
Time frame: 60 ± 5 days
significant change of serum-ferritin under supplementation
3 secondary outcomes
Blood Pressure
Time frame: 60 ± 5 days
Blood Sugar
Time frame: 60 ± 5 days
Lipid Status
Time frame: 60 ± 5 days
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 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron in people with Iron Deficiency (Without Anemia), run by Dr. Krayenbühl GmbH 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 10 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 11 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Serum-ferritin change (time frame: 60 ± 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.