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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05266794
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 21.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antioxidative Stress; End Stage Renal Disease on Dialysis	Drug: Alpha lipoic acid; Drug: Selenium	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 22, 2019
• Actual Primary Completion Date: Apr 23, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 25 hemodialysis patients who received their routine therapy only.
Active Comparator: Selenium 23 hemodialysis patients who received Selenium 200µg once daily with their routine therapy just after the dialysis sessions for 3 months.	Drug: Selenium; 23 patients who received Selenium 200µg once daily with their routine therapy just a
Active Comparator: Alpha Lipoic acid 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.	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.

Outcome Measures

Primary Outcome Measures

1. Change in miRNA-126 level [3 months]

   Fold expression

2. Change ROS level (ng/ml) [3 months]

   Using ELISA kit

3. Change in Co Q10 level (ng/ml) [3 months]

   Using ELISA kit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt	11566

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT05266794
• Other Study ID Numbers: MS 381/2018
• First Posted: Mar 4, 2022
• Last Update Posted: Mar 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ain Shams University: Oxidative stress; Antioxidants; mitochondrial function; CoQ10; miRNA-126; Hemodialysis
• Additional relevant MeSH terms: Kidney Failure, Chronic; Selenium; Thioctic Acid

Study Results

No Results Posted as of Mar 4, 2022