Oral Iron Supplementation for Patients With Chronic Kidney Disease

NCT ID: NCT05544513

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-12-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I

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

Group Type: EXPERIMENTAL

Ferrous sulfate 3 days week

Intervention Type: DRUG

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

Group II

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

Group Type: ACTIVE_COMPARATOR

Ferrous sulfate daily

Intervention Type: DRUG

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

Group III

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

Group Type: ACTIVE_COMPARATOR

Ferrous sulfate higher concentration

Intervention Type: DRUG

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

Interventions

Ferrous sulfate 3 days week

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

Intervention Type: DRUG

Ferrous sulfate daily

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

Intervention Type: DRUG

Ferrous sulfate higher concentration

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Denise Mafra

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

DeniseMafra14

Identifier Type: -

Identifier Source: org_study_id