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
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