Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis
NCT ID: NCT03912727
Last Updated: 2019-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2019-04-11
2019-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Alpha-lipoic acid
18 patients will receive alpha lipoic acid (thiotacidR) product with their standard therapy.
Alpha-Lipoic acid plus renal replacement therapy
Alpha lipoic acid (ALA) is a vitamin-like antioxidant
renal replacement therapy
standard renal replacement therapy
Control
18 patients will receive their standard therapy only.
renal replacement therapy
standard renal replacement therapy
Interventions
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Alpha-Lipoic acid plus renal replacement therapy
Alpha lipoic acid (ALA) is a vitamin-like antioxidant
renal replacement therapy
standard renal replacement therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged between18 - 60 years old.
3. Both sexes.
4. Patients who accept to participate in the study.
Exclusion Criteria
2. Smokers and alcoholics
3. Non-compliant patients
18 Years
60 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Rehab Werida
OTHER
Responsible Party
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Rehab Werida
Lecturer
Principal Investigators
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Zeinab A Zalat, Ass. Prof.
Role: STUDY_DIRECTOR
Al-Azhar University
Locations
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Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.
Cairo, , Egypt
Countries
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References
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Rivara MB, Yeung CK, Robinson-Cohen C, Phillips BR, Ruzinski J, Rock D, Linke L, Shen DD, Ikizler TA, Himmelfarb J. Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ10 Biomarker Trial. Am J Kidney Dis. 2017 Mar;69(3):389-399. doi: 10.1053/j.ajkd.2016.08.041. Epub 2016 Dec 4.
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.
Other Identifiers
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ALA in haemodialysis
Identifier Type: -
Identifier Source: org_study_id