Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Informed consent Demographics and history taking: Using Patient Data sheet 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. 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.

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

Conditions
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Hemodialysis Complication

Intervention / Treatment
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* Dietary Supplement: Alpha-Lipoic acid plus renal replacement therapy
* Other: renal replacement therapy


Participation Criteria
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Eligibility Criteria
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IPatients eligible for the study fulfilled the following inclusion criteria and free from exclusion criteria: Inclusion criteria: Clinical stable patients on hemodialysis for at least 3 months. Aged between18 - 60 years old. Both sexes. Patients who accept to participate in the study. Exclusion criteria: The patients suffering from other diseases, which may lead to oxidative stress, such as: Inflammatory diseases, hepatic or respiratory diseases … Smokers and alcoholics Non-compliant patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 36 patients with end-stage renal disease (ESRD) receiving hemodialysis 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 (thiotacidR) product with their standard therapy.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alpha-lipoic acid, Cardiovascular events, Hemodialysis