Chronic Renal DiseasePhase 2NCT05544513
Oral Iron Supplementation for Patients With Chronic Kidney Disease
A Phase 2 study testing Ferrous sulfate 3 days week, Ferrous sulfate daily and Ferrous sulfate higher concentration in people with Chronic Renal Disease and Iron-Deficiency Anemia, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The hypothesis of this research is that oral iron prescribed in a single dose in alternate day could mitigate the side effects with regard to intestinal microbiota, inflammation, oxidative stress and improve the hematological profile when compared to daily oral iron prescription Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Renal Disease, Iron-Deficiency Anemia, Anemia of Chronic Kidney Disease
- What is being tested?
- Ferrous sulfate 3 days week, Ferrous sulfate daily and Ferrous sulfate higher concentration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2022to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years Clinical diagnosis of Chronic Kidney Disease Conservative treatment group: chronic kidney disease stages 3 and 5
Who cannot join
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Autoimmune diseases
- Clinical diagnosis of infectious diseases
- Clinical diagnosis of Cancer
- Clinical diagnosis of AIDS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Iron Supplementation on Gut Microbiota in Patients With Chronic Kidney Disease
The hypothesis of this research is that oral iron prescribed in a single dose in alternate day could mitigate the side effects with regard to intestinal microbiota, inflammation, oxidative stress and improve the hematological profile when compared to daily oral iron prescription
Read the detailed description
chronic kidney disease triggers several changes in the body, anemia is one of the first disorders that appear in chronic kidney disease patients. The anemia in this patient is multifactorial, the main cause being relative erythropoietin deficiency, although iron deficiency is also common. In this context, the need for oral iron supplementation is a way of both treating iron deficiency and optimizing the use of agents that stimulate erythropoiesis. However, this replacement can cause iron overload, increasing the production of reactive oxygen species and, consequently, oxidative stress, and also alter the intestinal microbiota leading to poor iron absorption, worsening the prognosis of chronic kidney disease. The current routine for iron supplementation for these patients is to offer oral iron daily, which can be more harmful than when given on alternate days. However, there are few studies comparing the two prescriptions.
In this context, since no study to date has been carried out to show the aforementioned effects in the participant with chronic kidney disease, this randomized clinical trial aims to assess the effects of daily or alternate-day oral iron supplementation on gut microbiota composition in participants with chronic kidney disease (glomerular filtration rate (GFR) below 30 mL/min) for 3 months. The project will also compare the effects of both prescriptions on serum hepcidin levels, markers of oxidative stress and inflammation, and on routine hematological and biochemical parameters.
- Conditions
- Chronic Renal Disease, Iron-Deficiency Anemia, Anemia of Chronic Kidney Disease, Dysbiosis
- Being tested
- Ferrous sulfate 3 days week, Ferrous sulfate daily, Ferrous sulfate higher concentration
- Keywords
- hepcidin, inflammation
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Iron-Deficiency, Dysbiosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfate 3 days weekDrug
Participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays
Ferrous sulfate dailyDrug
Participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays)
Ferrous sulfate higher concentrationDrug
Participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays Receives: Drug: Ferrous sulfate 3 days week |
| Group II | Active comparator | participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays) Receives: Drug: Ferrous sulfate daily |
| Group III | Active comparator | participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays Receives: Drug: Ferrous sulfate higher concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron
cytokines plasma levels
Measured: 2 months
Secondary outcomes (1)
Change in uremic toxin plasma levels after supplementation with oral iron
Get blood samples to evaluate the supplementation effects in uremic toxins such as indoxyl sulfate, p-cresyl sulfate
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Aug 2022
- Primary completion29 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544513
- Sponsor's protocol ID
- DeniseMafra14
- Status last verified
- Apr 2025
- First submitted
- 4 Jan 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Iron Supplementation on Gut Microbiota in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05544513
- Acronym / sponsor ID
- DeniseMafra14
- Conditions
- Chronic Renal Disease, Iron-Deficiency Anemia, Anemia of Chronic Kidney Disease, Dysbiosis
- Keywords
- hepcidin, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Sep 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.
The hypothesis of this research is that oral iron prescribed in a single dose in alternate day could mitigate the side effects with regard to intestinal microbiota, inflammation, oxidative stress and improve the hematological profile when compared to daily oral iron prescription
Detailed description
chronic kidney disease triggers several changes in the body, anemia is one of the first disorders that appear in chronic kidney disease patients. The anemia in this patient is multifactorial, the main cause being relative erythropoietin deficiency, although iron deficiency is also common. In this context, the need for oral iron supplementation is a way of both treating iron deficiency and optimizing the use of agents that stimulate erythropoiesis. However, this replacement can cause iron overload, increasing the production of reactive oxygen species and, consequently, oxidative stress, and also alter the intestinal microbiota leading to poor iron absorption, worsening the prognosis of chronic kidney disease. The current routine for iron supplementation for these patients is to offer oral iron daily, which can be more harmful than when given on alternate days. However, there are few studies comparing the two prescriptions.
In this context, since no study to date has been carried out to show the aforementioned effects in the participant with chronic kidney disease, this randomized clinical trial aims to assess the effects of daily or alternate-day oral iron supplementation on gut microbiota composition in participants with chronic kidney disease (glomerular filtration rate (GFR) below 30 mL/min) for 3 months. The project will also compare the effects of both prescriptions on serum hepcidin levels, markers of oxidative stress and inflammation, and on routine hematological and biochemical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Ferrous sulfate 3 days weekparticipants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays |
| Group II | Active comparator | Drug: Ferrous sulfate dailyparticipants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays) |
| Group III | Active comparator | Drug: Ferrous sulfate higher concentrationparticipants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 to 75 years Clinical diagnosis of Chronic Kidney Disease Conservative treatment group: chronic kidney disease stages 3 and 5
Key exclusion criteria (7 listed)
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Autoimmune diseases
- Clinical diagnosis of infectious diseases
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 |
|---|---|---|
| Ferrous sulfate 3 days weekParticipants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays | Drug | Group I |
| Ferrous sulfate dailyParticipants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays) | Drug | Group II |
| Ferrous sulfate higher concentrationParticipants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays | Drug | Group III |
Primary outcome
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron
Time frame: 2 months
cytokines plasma levels
1 secondary outcome
Change in uremic toxin plasma levels after supplementation with oral iron
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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 Phase 2 study testing Ferrous sulfate 3 days week, Ferrous sulfate daily and Ferrous sulfate higher concentration in people with Chronic Renal Disease and Iron-Deficiency Anemia, run by Universidade Federal Fluminense at 1 site in Brazil.
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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron (time frame: 2 months). 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 3 Apr 2025.