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临床试验/NCT05544513
NCT05544513进行中(未招募)2 期

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

Universidade Federal Fluminense1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
6
试验地点
1
主要终点
Change in cytokines plasma levels measured by ELISA after supplementation with oral iron

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients pregnant
  • Using antibiotics in the last 3 months
  • Autoimmune diseases
  • Clinical diagnosis of infectious diseases
  • Clinical diagnosis of Cancer
  • Clinical diagnosis of AIDS

研究组 & 干预措施

Group I

Experimental

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

干预措施: Ferrous sulfate 3 days week (Drug)

Group II

Active Comparator

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

干预措施: Ferrous sulfate daily (Drug)

Group III

Active Comparator

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

干预措施: Ferrous sulfate higher concentration (Drug)

结局指标

主要结局

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

时间窗: 2 months

cytokines plasma levels

次要结局

  • Change in uremic toxin plasma levels after supplementation with oral iron(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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