Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis
Condition: Hemodialysis Complication
Study type: Interventional

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.
    

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.
    

Intervention name(s): Alpha-Lipoic acid plus renal replacement therapy; renal replacement therapy
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Alpha lipoic acid (ALA) is a vitamin-like antioxidant; standard renal replacement therapy
Other intervention name(s): Thiotacid ( Alpha-Lipoic acid 600 mg )
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: alpha-lipoic acid; Cardiovascular events; Hemodialysis