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Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis

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ClinicalTrials.gov Identifier: NCT03912727
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Al-Azhar University
Information provided by (Responsible Party):
Rehab Werida, Damanhour University

Brief 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.

Condition or disease Intervention/treatment Phase
Hemodialysis Complication Dietary Supplement: Alpha-Lipoic acid plus renal replacement therapy Other: renal replacement therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Official Title: A Protective Role of Alpha Lipoic Acid Against Possible Cardiovascular Events in Patients With Haemodialysis
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: 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




Primary Outcome Measures :
  1. Advanced glycation and oxidation end products (AGEs) [ Time Frame: three months ]
    Blood AGEs concentration was measured by fluorescence emission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912727


Contacts
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Contact: Rehabwerida Werida, Lecturer 01005359968 rehab_werida@hotmail.com
Contact: Hosny A Elewa, Ass. Prof hosnyelewa1960@yahoo.com

Locations
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Egypt
Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt. Recruiting
Cairo, Egypt
Contact: Hosny Elewa, Ass. Prof    01032100911    hosnyelewa1960@yahoo.com   
Sponsors and Collaborators
Rehab Werida
Al-Azhar University
Investigators
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Study Director: Zeinab A Zalat, Ass. Prof. Alazhar University

Publications:
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Responsible Party: Rehab Werida, Lecturer, Damanhour University
ClinicalTrials.gov Identifier: NCT03912727     History of Changes
Other Study ID Numbers: ALA in haemodialysis
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rehab Werida, Damanhour University:
alpha-lipoic acid
Cardiovascular events
Hemodialysis
Additional relevant MeSH terms:
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Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances