Hemodialysis ComplicationNCT03912727
Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis
A study testing Alpha-Lipoic acid plus renal replacement therapy and renal replacement therapy in people with Hemodialysis Complication, run by Rehab Werida at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Alpha-Lipoic acid plus renal replacement therapy and renal replacement therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.
Cairo
About this study
Official title: A Protective Role of Alpha Lipoic Acid Against Possible Cardiovascular Events in Patients With Haemodialysis
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.
Read the 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:
- 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:
- 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.
- Conditions
- Hemodialysis Complication
- Being tested
- Alpha-Lipoic acid plus renal replacement therapy, renal replacement therapy
- Keywords
- alpha-lipoic acid, Cardiovascular events, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic acid plus renal replacement therapyDietary supplement
Also called Thiotacid ( Alpha-Lipoic acid 600 mg )
Alpha lipoic acid (ALA) is a vitamin-like antioxidant
renal replacement therapyOther
standard renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Alpha-lipoic acid | Experimental | 18 patients will receive alpha lipoic acid (thiotacidR) product with their standard therapy. Receives: Dietary Supplement: Alpha-Lipoic acid plus renal replacement therapy; Other: renal replacement therapy |
| Control | Placebo comparator | 18 patients will receive their standard therapy only. Receives: Other: renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced glycation and oxidation end products (AGEs)
Blood AGEs concentration was measured by fluorescence emission
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start11 Apr 2019
- Primary completion30 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Zeinab A Zalat, Ass. Prof., Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912727
- Sponsor's protocol ID
- ALA in haemodialysis
- Status last verified
- Dec 2019
- First submitted
- 9 Apr 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27927588Liakopoulos 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.
PubMed 30774749
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protective Role of Alpha Lipoic Acid Against Possible Cardiovascular Events in Patients With Haemodialysis
- ClinicalTrials.gov ID
- NCT03912727
- Acronym / sponsor ID
- ALA in haemodialysis
- Conditions
- Hemodialysis Complication
- Keywords
- alpha-lipoic acid, Cardiovascular events, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alpha-lipoic acid | Experimental | Dietary Supplement: Alpha-Lipoic acid plus renal replacement therapy, Other: renal replacement therapy18 patients will receive alpha lipoic acid (thiotacidR) product with their standard therapy. |
| Control | Placebo comparator | Other: renal replacement therapy18 patients will receive their standard therapy only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Lipoic acid plus renal replacement therapyAlso: Thiotacid ( Alpha-Lipoic acid 600 mg )Alpha lipoic acid (ALA) is a vitamin-like antioxidant | Dietary supplement | Alpha-lipoic acid |
| renal replacement therapystandard renal replacement therapy | Other | Alpha-lipoic acid, Control |
Primary outcome
Advanced glycation and oxidation end products (AGEs)
Time frame: three months
Blood AGEs concentration was measured by fluorescence emission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Background: PubMed 27927588Rivara 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.
- Background: PubMed 30774749Liakopoulos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeinab A Zalat, Ass. Prof. study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Lipoic acid plus renal replacement therapy and renal replacement therapy in people with Hemodialysis Complication, run by Rehab Werida at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced glycation and oxidation end products (AGEs) (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03912727, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.