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Completed

NCT Number: NCT05266794

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

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.

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Key information

Conditions

Antioxidative Stress End Stage Renal Disease on Dialysis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, 11566, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • prevalent hemodialysis patients

Exclusion criteria

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

Treatment and study plan

Alpha lipoic acid

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.

selenium

Drug

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

Primary outcomes

  1. Change in miRNA-126 level

    Time frame: 3 months

    Fold expression

  2. Change ROS level (ng/ml)

    Time frame: 3 months

    Using ELISA kit

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

    Time frame: 3 months

    Using ELISA kit

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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