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NCT05266794 Clinical Trial

A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients

End Stage Renal Disease on Dialysis Clinical Trial

Official title:
A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients Randomized, Prospective, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05266794
Other study ID # MS 381/2018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 22, 2019
Est. completion date April 30, 2019

Study information
Verified date March 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An Open labeled, Paralled, Randomized, Prospective, study was conducted on 60 patients who were randomized into 3 groups, 22, 20 and 18 patients in Control, Selenium and, Thiotacid groups respectively. Serum levels of ROS, CoQ10, and miRNA-126 were assessed at base line and after three months for all patients.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date April 30, 2019
Est. primary completion date April 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - prevalent hemodialysis patients Exclusion Criteria: - Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Alpha lipoic acid
20 patients who received Alpha Lipoic acid (ALA) (Thiotex fort®) 600mg once daily with their routine therapy just after the dialysis sessions for 3 months.
• Selenium
23 patients who received Selenium 200µg once daily with their routine therapy just a

Locations
Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in miRNA-126 level Fold expression 3 months
Primary Change ROS level (ng/ml) Using ELISA kit 3 months
Primary Change in Co Q10 level (ng/ml) Using ELISA kit 3 months
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