Back to resultsA Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients
Primary Purpose
Antioxidative Stress, End Stage Renal Disease on Dialysis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Alpha lipoic acid
Selenium
Sponsored by
About this trial
This is an interventional prevention trial for Antioxidative Stress focused on measuring Oxidative stress, Antioxidants, mitochondrial function, CoQ10, miRNA-126, Hemodialysis
Eligibility Criteria
Inclusion Criteria:
- prevalent hemodialysis patients
Exclusion Criteria:
- Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Selenium
Alpha Lipoic acid
Arm Description
25 hemodialysis patients who received their routine therapy only.
23 hemodialysis patients who received Selenium 200µg once daily with their routine therapy just after the dialysis sessions for 3 months.
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.
Outcomes
Primary Outcome Measures
Change in miRNA-126 level
Fold expression
Change ROS level (ng/ml)
Using ELISA kit
Change in Co Q10 level (ng/ml)
Using ELISA kit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05266794
Brief Title
A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antioxidative Stress, End Stage Renal Disease on Dialysis
Keywords
Oxidative stress, Antioxidants, mitochondrial function, CoQ10, miRNA-126, Hemodialysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
25 hemodialysis patients who received their routine therapy only.
Arm Title
Selenium
Arm Type
Active Comparator
Arm Description
23 hemodialysis patients who received Selenium 200µg once daily with their routine therapy just after the dialysis sessions for 3 months.
Arm Title
Alpha Lipoic acid
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Alpha lipoic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Selenium
Intervention Description
23 patients who received Selenium 200µg once daily with their routine therapy just a
Primary Outcome Measure Information:
Title
Change in miRNA-126 level
Description
Fold expression
Time Frame
3 months
Title
Change ROS level (ng/ml)
Description
Using ELISA kit
Time Frame
3 months
Title
Change in Co Q10 level (ng/ml)
Description
Using ELISA kit
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prevalent hemodialysis patients
Exclusion Criteria:
Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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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
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