Oral Iron Supplementation for Patients With Chronic Kidney Disease

Phase 2

Active, not recruiting

• Conditions: Chronic Renal Disease; Iron-Deficiency Anemia; Anemia of Chronic Kidney Disease; Dysbiosis
• Interventions: Drug: Ferrous sulfate 3 days week; Drug: Ferrous sulfate daily; Drug: Ferrous sulfate higher concentration

• Registration Number: NCT05544513
• Lead Sponsor: Universidade Federal Fluminense

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.

Study Timeline

• Study First Submitted: 2022-01-04
• Study Start: 2022-08-01
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-12-29
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Ferrous sulfate 3 days week	participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays
Group II	Ferrous sulfate daily	participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays)
Group III	Ferrous sulfate higher concentration	participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays

Primary Outcome Measures

Name	Time	Method
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron	2 months	cytokines plasma levels

Secondary Outcome Measures

Name	Time	Method
Change in uremic toxin plasma levels after supplementation with oral iron	2 months	Get blood samples to evaluate the supplementation effects in uremic toxins such as indoxyl sulfate, p-cresyl sulfate

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de Janeiro, RJ, Brazil