Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis

Hemodialysis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912727
• Other study ID #: ALA in haemodialysis
• Status: Completed
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: December 2019
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

Dietary Supplement:
• Alpha-Lipoic acid plus renal replacement therapy
Alpha lipoic acid (ALA) is a vitamin-like antioxidant

Other:
• renal replacement therapy
standard renal replacement therapy

Locations

Country	Name	City	State
Egypt	Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Rehab Werida	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Liakopoulos V, Roumeliotis S, Bozikas A, Eleftheriadis T, Dounousi E. Antioxidant Supplementation in Renal Replacement Therapy Patients: Is There Evidence? Oxid Med Cell Longev. 2019 Jan 15;2019:9109473. doi: 10.1155/2019/9109473. eCollection 2019. Review. — View Citation

Rivara MB, Yeung CK, Robinson-Cohen C, Phillips BR, Ruzinski J, Rock D, Linke L, Shen DD, Ikizler TA, Himmelfarb J. Effect of Coenzyme Q(10) on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ(10) Biomarker Trial. Am J Kidney Dis. 2017 Mar;69(3):389-399. doi: 10.1053/j.ajkd.2016.08.041. Epub 2016 Dec 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advanced glycation and oxidation end products (AGEs)	Blood AGEs concentration was measured by fluorescence emission	three months