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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Antioxidative Stress; End Stage Renal Disease on Dialysis

Treatments: Drug: Alpha lipoic acid; Drug: Selenium

Study type: Interventional

Funder types: Other

Identifiers

NCT05266794

MS 381/2018

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• prevalent hemodialysis patients

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 3 patient groups

Control

No Intervention group

Description:

25 hemodialysis patients who received their routine therapy only.

Selenium

Active Comparator group

Description:

23 hemodialysis patients who received Selenium 200µg once daily with their routine therapy just after the dialysis sessions for 3 months.

Treatment:

Drug: Selenium

Alpha Lipoic acid

Active Comparator group

Description:

20 hemodialysispatients who received Alpha Lipoic acid (ALA) (Thiotex fort®) 600mg once daily with their routine therapy just after the dialysis sessions for 3 months.

Treatment:

Drug: Alpha lipoic acid