Oral Iron Supplementation for Patients With Chronic Kidney Disease
Primary Purpose
Chronic Renal Disease, Iron-Deficiency Anemia, Anemia of Chronic Kidney Disease
Status
Active
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ferrous sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Disease focused on measuring hepcidin, inflammation
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
Sites / Locations
- Denise Mafra
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
- Group I
Group II
Group III
Arm Description
participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays
participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays)
participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays
Outcomes
Primary Outcome Measures
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron
cytokines plasma levels
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05544513
First Posted
January 4, 2022
Last Updated
September 15, 2022
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT05544513
Brief Title
Oral Iron Supplementation for Patients With Chronic Kidney Disease
Official Title
Effects of Oral Iron Supplementation on Gut Microbiota in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
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
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Disease, Iron-Deficiency Anemia, Anemia of Chronic Kidney Disease, Dysbiosis
Keywords
hepcidin, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
- Group I
Arm Type
Experimental
Arm Description
participants will receive one ferrous sulfate capsule (120 mg of elemental iron) on Mondays, Wednesdays and Fridays
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
participants will receive one ferrous sulfate (120 mg of elemental iron) capsule daily (except on Sundays)
Arm Title
Group III
Arm Type
Experimental
Arm Description
participants will receive one ferrous sulfate capsule (240mg of elemental iron) on Mondays, Wednesdays and fridays
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate
Intervention Description
Ferrous sulfate supplementation
Primary Outcome Measure Information:
Title
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron
Description
cytokines plasma levels
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in uremic toxin plasma levels after supplementation with oral iron
Description
Get blood samples to evaluate the supplementation effects in uremic toxins such as indoxyl sulfate, p-cresyl sulfate
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260050
Country
Brazil
12. IPD Sharing Statement
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Oral Iron Supplementation for Patients With Chronic Kidney Disease
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