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

NCT ID: NCT05266794

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Antioxidative Stress End Stage Renal Disease on Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

25 hemodialysis patients who received their routine therapy only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Selenium

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

Group Type ACTIVE_COMPARATOR

Selenium

Intervention Type DRUG

23 patients who received Selenium 200µg once daily with their routine therapy just a

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.

Group Type ACTIVE_COMPARATOR

Alpha lipoic acid

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Selenium

23 patients who received Selenium 200µg once daily with their routine therapy just a

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* prevalent hemodialysis patients

Exclusion Criteria

* Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS 381/2018

Identifier Type: -

Identifier Source: org_study_id

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