Iron Deficiency (Without Anemia)NCT05467423
Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome
A study testing Iron in people with Iron Deficiency (Without Anemia), run by University of Zurich at 1 site in Switzerland.
Trial summary
Iron deficiency is a common problem that is often treated with the administration of oral iron. Most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria. This influence is usually undesirable and should be kept as small as possible. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- 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?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jan 2023to 30 Sep 2023
- 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
- Healthy volunteers accepted
- 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 (18-25kg/m2)
Show all 9Show fewer
- Serum-ferritin ≤30ng/ml
- No anemia (hemoglobin ≥117g/l)
- No intake of dietary supplements for at least 4 weeks
Who cannot join
- Pregnancy
- Hypermenorrhea (more than 5 unties/tampons per day)
- Chronic inflammatory disease, psychiatric disorders
- Hypersensitivity to iron supplements
- chronic kidney disease (creatinine >80 µmol/l)
- Liver disease (ALT >35 U/l)
- Hypo- or Hyperthyroidism (TSH not between 0.16-4.25 mU/l)
- Intake of medicines that interact with oral iron supplementation (e.g. PPI)*
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Clinical Trial to Evaluate the Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome in Non-anemic Iron-deficient Females
Iron deficiency is a common problem that is often treated with the administration of oral iron.
Most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria.
This influence is usually undesirable and should be kept as small as possible. With lower iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the intestinal bacteria composition is to be expected.
Read the detailed description
Iron deficiency affects about one in five premenopausal women. The first line treatment for patients with iron deficiency is an oral therapy with iron-supplements, another option is the intravenous iron supplementation.
The oral supplementation causes side-effects such as nausea, vomiting, abdominal pain and many more in a lot of patients. There is a positive correlation between the appearance of gastrointestinal side-effects and the applicated iron dose.
Only a low fraction of orally taken iron is actually absorbed, even in patients with iron-deficiency. Since only a fraction of the orally administered iron is actually absorbed, the toxicity of high concentrations of iron in the gastrointestinal tract and the altered selection advantages of the bacteria presumably leads to microbiome changes.
The unabsorbed iron is potentially changing the microbiome, which leads to undesirable side effects.
With low-dose iron-supplementation the amount of unabsorbed iron is smaller, therefore a dosage dependent microbiome change would be expected.
The aim of the study is to determine the magnitude of the microbiome response to daily iron substitution with 12mg and 100mg.
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Iron
- Keywords
- Iron, Microbiome, Gut Bacteria
- 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
4 weeks of daily oral iron therapy. The subjects administer the therapy themselves.
| Study group | Role | What they receive |
|---|---|---|
| Standard-dose | Active comparator | The standard-dose arm takes one 100mg of iron per day together with a meal, no matter breakfast, lunch or dinner - one tablet a day. Receives: Dietary Supplement: Iron |
| Low-dose | Experimental | The low-dose arm 12mg of iron a day. The first 6mg tablet in the morning on an empty stomach and the second 6mg tablet in the evening either one hour before or after eating - two tablets a day. Receives: Dietary Supplement: Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome diversity and oral iron therapy
The microbiome is analyzed using stool samples. A stool sample is taken before and after the 4 weeks period. The low-dose arm is expected to have a smaller decrease compared to the standard-dose arm. The microbiome composition is measured using 16S rDNA gene amplicon sequencing. The results are analysed using the Shannon-Index to include diversity as well as abundance.
Measured: 4 weeks
Secondary outcomes (1)
Side-effects of treatment
Adverse events will be assessed on a report form after 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start4 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 Sep 2023
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467423
- Sponsor's protocol ID
- IronGutMicrobiome
- Status last verified
- Dec 2023
- First submitted
- 5 Jul 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Clinical Trial to Evaluate the Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome in Non-anemic Iron-deficient Females
- ClinicalTrials.gov ID
- NCT05467423
- Acronym / sponsor ID
- IronGutMicrobiome
- Conditions
- Iron Deficiency (Without Anemia)
- Keywords
- Iron, Microbiome, Gut Bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Jul 2022 (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 a common problem that is often treated with the administration of oral iron.
Most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria.
This influence is usually undesirable and should be kept as small as possible. With lower iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the intestinal bacteria composition is to be expected.
Detailed description
Iron deficiency affects about one in five premenopausal women. The first line treatment for patients with iron deficiency is an oral therapy with iron-supplements, another option is the intravenous iron supplementation.
The oral supplementation causes side-effects such as nausea, vomiting, abdominal pain and many more in a lot of patients. There is a positive correlation between the appearance of gastrointestinal side-effects and the applicated iron dose.
Only a low fraction of orally taken iron is actually absorbed, even in patients with iron-deficiency. Since only a fraction of the orally administered iron is actually absorbed, the toxicity of high concentrations of iron in the gastrointestinal tract and the altered selection advantages of the bacteria presumably leads to microbiome changes.
The unabsorbed iron is potentially changing the microbiome, which leads to undesirable side effects.
With low-dose iron-supplementation the amount of unabsorbed iron is smaller, therefore a dosage dependent microbiome change would be expected.
The aim of the study is to determine the magnitude of the microbiome response to daily iron substitution with 12mg and 100mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-dose | Active comparator | Dietary Supplement: IronThe standard-dose arm takes one 100mg of iron per day together with a meal, no matter breakfast, lunch or dinner - one tablet a day. |
| Low-dose | Experimental | Dietary Supplement: IronThe low-dose arm 12mg of iron a day. The first 6mg tablet in the morning on an empty stomach and the second 6mg tablet in the evening either one hour before or after eating - two tablets a day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Informed Consent as documented by signature
- Female gender
- Premenopausal
- Age > 18 years
- Regular menstrual cycle
Key exclusion criteria (8 listed)
- Pregnancy
- Hypermenorrhea (more than 5 unties/tampons per day)
- Chronic inflammatory disease, psychiatric disorders
- Hypersensitivity to iron supplements
- chronic kidney disease (creatinine >80 µmol/l)
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 |
|---|---|---|
| Iron4 weeks of daily oral iron therapy. The subjects administer the therapy themselves. | Dietary supplement | Low-dose, Standard-dose |
Primary outcome
Microbiome diversity and oral iron therapy
Time frame: 4 weeks
The microbiome is analyzed using stool samples. A stool sample is taken before and after the 4 weeks period. The low-dose arm is expected to have a smaller decrease compared to the standard-dose arm. The microbiome composition is measured using 16S rDNA gene amplicon sequencing. The results are analysed using the Shannon-Index to include diversity as well as abundance.
1 secondary outcome
Side-effects of treatment
Time frame: 4 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 29 Dec 2023.
- Individual participant dataSharing planned: No
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 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 9 inclusion and 8 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 29 Dec 2023. 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?
Microbiome diversity and oral iron therapy (time frame: 4 weeks). 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 29 Dec 2023.