Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis

NCT03912727 | Completed

• 1 other identifier: ALA in haemodialysis
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication

Keywords

alpha-lipoic acid; Cardiovascular events; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Advanced glycation and oxidation end products (AGEs)

  Blood AGEs concentration was measured by fluorescence emission

  three months

Study Arms (2)

Alpha-lipoic acid

EXPERIMENTAL

18 patients will receive alpha lipoic acid (thiotacidR) product with their standard therapy.

Dietary Supplement: Alpha-Lipoic acid plus renal replacement therapy; Other: renal replacement therapy

Control

PLACEBO COMPARATOR

18 patients will receive their standard therapy only.

Other: renal replacement therapy

Interventions

Alpha-Lipoic acid plus renal replacement therapy DIETARY_SUPPLEMENT

Alpha lipoic acid (ALA) is a vitamin-like antioxidant

Also known as: Thiotacid ( Alpha-Lipoic acid 600 mg )

Alpha-lipoic acid

renal replacement therapy OTHER

standard renal replacement therapy

Alpha-lipoic acid; Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rehab Werida: lead
• Al-Azhar University: collaborator

Study Sites (1)

Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 27927588 BACKGROUND

• 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.

  PMID: 30774749 BACKGROUND

MeSH Terms

Interventions

Thioctic Acid; Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Therapeutics

Study Officials

• Zeinab A Zalat, Ass. Prof.

  Al-Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: April 11, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 1, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)