Oral Iron Supplementation for Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Ferrous sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepcidin, inflammation