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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05266794
Enrollment
68
Registered
2022-03-04
Start date
2019-01-22
Completion date
2019-04-30
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antioxidative Stress, End Stage Renal Disease on Dialysis

Keywords

Oxidative stress, Antioxidants, mitochondrial function, CoQ10, miRNA-126, Hemodialysis

Brief 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.

Interventions

DRUGAlpha 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.

DRUGSelenium

23 patients who received Selenium 200µg once daily with their routine therapy just a

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* prevalent hemodialysis patients

Exclusion criteria

* Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Change in miRNA-126 level3 monthsFold expression
Change ROS level (ng/ml)3 monthsUsing ELISA kit
Change in Co Q10 level (ng/ml)3 monthsUsing ELISA kit

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026