Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis

December 23, 2019 updated by: Rehab Werida

A Protective Role of Alpha Lipoic Acid Against Possible Cardiovascular Events in Patients With Haemodialysis

Evaluate the association between possible benefit effects of oral administration of alpha lipoic acid by patients with hemodialysis and the possible reduction in cardiovascular events (CVEs); using Advanced glycation end products (AGEs) as a measure to assess endothelium function which correlate with CVEs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design: double blind, Parallel, Randomized, Prospective, Controlled study. Setting: Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.

Sample size:

36 patients with end-stage renal disease (ESRD) receiving dialysis treatment will be enrolled in the study and the patients will be identified by coded numbers to maintain the privacy.

Patients will be randomized into two groups each group includes 18 patients:

Control Group: 18 patients will receive their standard therapy only. Tested Group: 18 patients will receive alpha-lipoic acid (thiotacid R) product with their standard therapy.

Materials:

Thiotacid R 600 mg tablet. Each tablet contains: Thioctic acid (Alpha-lipoic acid) 600 mg; a product of EVA pharma, Cairo, Egypt.

Methods:

All Patients will be subjected to the following:

  1. Informed consent
  2. Demographics and history taking: Using Patient Data sheet

  3. Laboratory evaluation including:

    A- Routine laboratory measurements as hemoglobin, calcium, phosphate, and albumin will be determined.

    The assessment will be done in 2 occasions:

    i. At Baseline (before the beginning of the treatment) for all groups ii. After 3 months of addition of alpha lipoic acid to their standard therapy for the tested group.

  4. Follow up:

A- During-treatment follows up of the patients:

All patients will be followed up during the study for treatment tolerability by assessing adverse effects, and compliance to drug regimen.

Drug regimen: - the patients in tested group will administered Thiotacid 600 mg; orally once daily for 3 months as add on the standard therapy that are receiving.

Patients will be interviewed weekly through face to face contact with the clinical pharmacist regarding treatment tolerability, and through telephone calls in between these weekly meetings.

B- Post-treatment follows up of the patients:

All patients in control group will be followed up clinically after 3 months from the start of the study and all laboratory examinations will be carried out.

All patients in tested group will be followed up clinically after 3 months from the start of treatment and all laboratory examinations will be carried out.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

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
        • Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

IPatients eligible for the study fulfilled the following inclusion criteria and free from exclusion criteria:

Inclusion criteria:

  1. Clinical stable patients on hemodialysis for at least 3 months.
  2. Aged between18 - 60 years old.
  3. Both sexes.
  4. Patients who accept to participate in the study.

Exclusion criteria:

  1. The patients suffering from other diseases, which may lead to oxidative stress, such as: Inflammatory diseases, hepatic or respiratory diseases …
  2. Smokers and alcoholics
  3. Non-compliant patients

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha-lipoic acid
18 patients will receive alpha lipoic acid (thiotacidR) product with their standard therapy.
Dietary supplement: Alpha-Lipoic acid plus renal replacement therapy
Alpha lipoic acid (ALA) is a vitamin-like antioxidant
Other Names:
  • Thiotacid ( Alpha-Lipoic acid 600 mg )
Other: renal replacement therapy
standard renal replacement therapy
Placebo Comparator: Control
18 patients will receive their standard therapy only.
Other: renal replacement therapy
standard renal replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced glycation and oxidation end products (AGEs)
Time Frame: three months
Blood AGEs concentration was measured by fluorescence emission
three months

Collaborators and Investigators

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

Sponsor

Rehab Werida

Collaborators

Al-Azhar University

Investigators

  • Study Director: Zeinab A Zalat, Ass. Prof., Alazhar university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 11, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALA in haemodialysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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