Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05544513 |
| Other study ID # |
DeniseMafra14 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
December 30, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Universidade Federal Fluminense |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
