Oral Iron Supplementation for Patients With Chronic Kidney Disease

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dysbiosis; Anemia of Chronic Kidney Disease; Chronic Renal Disease; Iron-Deficiency Anemia
• Intervention / Treatment: Drug: Ferrous sulfate 3 days week; Drug: Ferrous sulfate daily; Drug: Ferrous sulfate higher concentration

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22260050
      • Denise Mafra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group II; participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays)	Drug: Ferrous sulfate daily; Participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays)
Experimental: Group I; participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays	Drug: Ferrous sulfate 3 days week; Participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays
Active Comparator: Group III; participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays	Drug: Ferrous sulfate higher concentration; Participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron	cytokines plasma levels	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 months

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: hepcidin; inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Anemia, Hypochromic; Iron Metabolism Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Kidney Failure, Chronic; Anemia; Dysbiosis; Iron Deficiencies
• Other Study ID Numbers: DeniseMafra14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No