Oral Iron Supplementation for Patients With Chronic Kidney Disease

NCT05544513 | Active Not Recruiting Phase 2

• 1 other identifier: DeniseMafra14
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

hepcidin; inflammation

Outcome Measures

Primary Outcomes (1)

• Change in cytokines plasma levels measured by ELISA after supplementation with oral iron

  cytokines plasma levels

  2 months

Secondary Outcomes (1)

• Change in uremic toxin plasma levels after supplementation with oral iron

  2 months

Study Arms (3)

Group I

EXPERIMENTAL

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

Drug: Ferrous sulfate 3 days week

Group II

ACTIVE COMPARATOR

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

Drug: Ferrous sulfate daily

Group III

ACTIVE COMPARATOR

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

Drug: Ferrous sulfate higher concentration

Interventions

Ferrous sulfate 3 days week DRUG

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

Group I

Ferrous sulfate daily DRUG

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

Group II

Ferrous sulfate higher concentration DRUG

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

Group III

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years Clinical diagnosis of Chronic Kidney Disease Conservative treatment group: chronic kidney disease stages 3 and 5

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Dysbiosis; Inflammation

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: September 16, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

BR (1)