Oral Iron Supplementation for Patients With Chronic Kidney Disease

• Sponsor: Universidade Federal Fluminense (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05544513
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 53
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Disease; Iron-Deficiency Anemia; Anemia of Chronic Kidney Disease; Dysbiosis	Drug: Ferrous sulfate	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effects of Oral Iron Supplementation on Gut Microbiota in Patients With Chronic Kidney Disease
• Actual Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 29, 2023
• Anticipated Study Completion Date: Dec 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in cytokines plasma levels measured by ELISA after supplementation with oral iron [2 months]

   cytokines plasma levels

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denise Mafra	Rio de Janeiro	RJ	Brazil	22260050

Sponsors and Collaborators

• Universidade Federal Fluminense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidade Federal Fluminense
• ClinicalTrials.gov Identifier: NCT05544513
• Other Study ID Numbers: DeniseMafra14
• First Posted: Sep 16, 2022
• Last Update Posted: Sep 16, 2022
• Last Verified: Sep 1, 2022

• 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
• Keywords provided by Universidade Federal Fluminense: hepcidin; inflammation
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia; Anemia, Iron-Deficiency; Dysbiosis

Study Results

No Results Posted as of Sep 16, 2022