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Oral Iron Supplementation for Patients With Chronic Kidney Disease

Effects of Oral Iron Supplementation on Gut Microbiota in Patients With Chronic Kidney Disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05544513
Enrollment
6
Registered
2022-09-16
Start date
2022-08-01
Completion date
2026-12-30
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Chronic Kidney Disease, Chronic Renal Disease, Dysbiosis, Iron-Deficiency Anemia

Keywords

hepcidin, inflammation

Brief 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

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.

Interventions

DRUGFerrous sulfate 3 days week

Participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays

DRUGFerrous sulfate daily

Participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays)

DRUGFerrous sulfate higher concentration

Participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays

Sponsors

Universidade Federal Fluminense
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Aged 18 to 75 years Clinical diagnosis of Chronic Kidney Disease Conservative treatment group: chronic kidney disease stages 3 and 5

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron2 monthscytokines plasma levels

Secondary

MeasureTime frameDescription
Change in uremic toxin plasma levels after supplementation with oral iron2 monthsGet blood samples to evaluate the supplementation effects in uremic toxins such as indoxyl sulfate, p-cresyl sulfate

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026