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CompletedNCT05266794Updated Mar 4, 2022

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

A Phase 4 interventional study of Alpha lipoic acid and Selenium in Antioxidative Stress and End Stage Renal Disease on Dialysis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Jan 2019, registered Feb 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Antioxidative Stress
  • End Stage Renal Disease on Dialysis

Keywords

  • Oxidative stress
  • Antioxidants
  • mitochondrial function
  • CoQ10
  • miRNA-126
  • Hemodialysis
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 68 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • prevalent hemodialysis patients

Exclusion criteria

Exclusion Criteria:

  • Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • 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

  • 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

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

06

What researchers measure

Primary outcomes

  1. Change in miRNA-126 level

    Fold expression

    Time frame: 3 months

  2. Change ROS level (ng/ml)

    Using ELISA kit

    Time frame: 3 months

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

    Using ELISA kit

    Time frame: 3 months

07

Study locations

1 site
  • Ain Shams University
    Cairo, 11566, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05266794
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Mar 4, 2022
Start date
Jan 22, 2019
Primary completion
Apr 23, 2019
Completion
Apr 30, 2019
Last update
Mar 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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