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

March 1, 2022 updated by: Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • prevalent hemodialysis patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in miRNA-126 level
Time Frame: 3 months
Fold expression
3 months
Change ROS level (ng/ml)
Time Frame: 3 months
Using ELISA kit
3 months
Change in Co Q10 level (ng/ml)
Time Frame: 3 months
Using ELISA kit
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 22, 2019

Primary Completion (ACTUAL)

April 23, 2019

Study Completion (ACTUAL)

April 30, 2019

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (ACTUAL)

March 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 381/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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