Hemodialysis ComplicationPhase 3NCT06286098
Alpha Lipoic Acid in Pediatrics on Hemodialysis
A Phase 3 study testing Alpha lipoic acid in people with Hemodialysis Complication and Pediatric Kidney Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are: Will the use of alpha lipoic acid lower cardiovascular events in that population? Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Hemodialysis Complication, Pediatric Kidney Disease, Cardiovascular Complication
- What is being tested?
- Alpha lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2025to 1 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis.
- The ability to swallow capsules will be enrolled in the study.
Who cannot join
- Participants who suffered from severe congestive heart failure
- Participants suffering from inflammatory diseases or other diseases that may increase oxidative stress.
- Participants taking supplements that decrease oxidative stress or inflammatory markers
- Participants with hypersensitivity to alpha lipoic acid
- Participants who are non-compliant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
New Pediatrics Hospital, Faculty of Medicine, Ain Shams University
Cairo, El Weili, 11381
About this study
Official title: Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:
- Will the use of alpha lipoic acid lower cardiovascular events in that population?
- Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?
- Will the drug cause side effects?
Read more
Participants will:
- take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.
- be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)
- be monitored for the occurrence of side effects
- give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme
- undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet.
Read the detailed description
A Double-Blinded, Paralleled, Randomized, Placebo-Controlled Clinical Trial will be conducted at the Pediatric Nephrology and Dialysis Unit, Children's Hospital, Ain Shams University, Cairo, Egypt to detect the efficacy of alpha lipoic acid in reducing cardiovascular events by reducing oxidative stress-mediated endothelial dysfunction in pediatric population on regular hemodialysis by assessment of:
- E-selectin as an Endothelial biomarker
- SOD as an Oxidative stress biomarker
- Indicators of CVS dysfunction by;
- Duplex ultrasonography
- Echocardiogram with stress on Ejection Fraction
- Intimal medial thickness
- Occurrence of CVS events
- Being tested
- Alpha lipoic acid, Placebo
- Keywords
- Alpha Lipoic Acid, alpha-lipoic acid, Thioctic acid, Hemodialysis, E-selectin, eselectin, Children Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acidDrug
Also called Thioctic Acid
THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA
PlaceboOther
Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid.
| Study group | Role | What they receive |
|---|---|---|
| (Alpha lipoic acid) Active Group | Experimental | Alpha Lipoic Acid orally along with the standard care of therapy for a duration of 6 months.
Dose: 600 mg once daily. Receives: Drug: Alpha lipoic acid |
| (Placebo) Control Group | Placebo comparator | Placebo along with the standard care of therapy for a duration of 6 months.
Dose: One Tablet daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of E-Selectin
The effect of ALA supplementation on the serum level of E-Selectin in pediatric patients on regular hemodialysis.
Measured: at baseline and after the duration of treatment (6 months)
Secondary outcomes (3)
Serum levels of superoxide dismutase (SOD)
The effect of ALA supplementation on the serum level of SOD in pediatric patients on regular hemodialysis.
Measured: at baseline and after the duration of treatment (6 months)
Number of cardiovascular events
Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring
Measured: for the duration of treatment (6 months)
Number of Adverse effects
Evaluation of the safety of ALA supplementation in pediatric hemodialysis patients in terms of proportion of adverse drug events and complications.
Measured: for the duration of treatment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start2 Feb 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Eva Pharma
- Responsible party
- Principal investigator, mahmoud mohsen, Ain Shams University
- Investigators
- Mahmoud Mohsen, Pharmacist, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286098
- Sponsor's protocol ID
- ALA in Pediatrics on HD
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fogacci F, Rizzo M, Krogager C, Kennedy C, Georges CMG, Knezevic T, Liberopoulos E, Vallee A, Perez-Martinez P, Wenstedt EFE, Satrauskiene A, Vrablik M, Cicero AFG. Safety Evaluation of alpha-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies. Antioxidants (Basel). 2020 Oct 19;9(10):1011. doi: 10.3390/antiox9101011.
PubMed 33086555Haghighatdoost F, Hariri M. The effect of alpha-lipoic acid on inflammatory mediators: a systematic review and meta-analysis on randomized clinical trials. Eur J Pharmacol. 2019 Apr 15;849:115-123. doi: 10.1016/j.ejphar.2019.01.065. Epub 2019 Feb 2.
PubMed 30721699Huang EA, Gitelman SE. The effect of oral alpha-lipoic acid on oxidative stress in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2008 Jun;9(3 Pt 2):69-73. doi: 10.1111/j.1399-5448.2007.00342.x. Epub 2008 Jan 22.
PubMed 18221433Li LC, Tain YL, Kuo HC, Hsu CN. Cardiovascular diseases morbidity and mortality among children, adolescents and young adults with dialysis therapy. Front Public Health. 2023 Apr 12;11:1142414. doi: 10.3389/fpubh.2023.1142414. eCollection 2023.
PubMed 37124791Malatino LS, Stancanelli B, Cataliotti A, Bellanuova I, Fatuzzo P, Rapisarda F, Leonardis D, Tripepi G, Mallamaci F, Zoccali C. Circulating E-selectin as a risk marker in patients with end-stage renal disease. J Intern Med. 2007 Oct;262(4):479-87. doi: 10.1111/j.1365-2796.2007.01841.x.
PubMed 17875185Al-Nami MS, Al-Kuraishy HM, Al-Gareeb AI. Impact of thioctic acid on glycemic indices and associated inflammatory-induced endothelial dysfunction in patients with type 2 diabetes mellitus: A case control study. Int J Crit Illn Inj Sci. 2020 Sep;10(Suppl 1):21-27. doi: 10.4103/IJCIIS.IJCIIS_62_19. Epub 2020 Sep 16.
PubMed 33376686
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT06286098
- Acronym / sponsor ID
- ALA in Pediatrics on HD
- Keywords
- Alpha Lipoic Acid, alpha-lipoic acid, Thioctic acid, Hemodialysis, E-selectin, eselectin, Children Kidney
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Eva Pharma
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 29 Feb 2024 (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.
The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:
- Will the use of alpha lipoic acid lower cardiovascular events in that population?
- Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?
- Will the drug cause side effects?
Participants will:
- take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.
- be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)
- be monitored for the occurrence of side effects
- give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme
- undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet.
Detailed description
A Double-Blinded, Paralleled, Randomized, Placebo-Controlled Clinical Trial will be conducted at the Pediatric Nephrology and Dialysis Unit, Children's Hospital, Ain Shams University, Cairo, Egypt to detect the efficacy of alpha lipoic acid in reducing cardiovascular events by reducing oxidative stress-mediated endothelial dysfunction in pediatric population on regular hemodialysis by assessment of:
- E-selectin as an Endothelial biomarker
- SOD as an Oxidative stress biomarker
- Indicators of CVS dysfunction by;
- Duplex ultrasonography
- Echocardiogram with stress on Ejection Fraction
- Intimal medial thickness
- Occurrence of CVS events
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Alpha lipoic acid) Active Group | Experimental | Drug: Alpha lipoic acidAlpha Lipoic Acid orally along with the standard care of therapy for a duration of 6 months. Dose: 600 mg once daily. |
| (Placebo) Control Group | Placebo comparator | Other: PlaceboPlacebo along with the standard care of therapy for a duration of 6 months. Dose: One Tablet daily. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis.
- The ability to swallow capsules will be enrolled in the study.
Key exclusion criteria (5 listed)
- Participants who suffered from severe congestive heart failure
- Participants suffering from inflammatory diseases or other diseases that may increase oxidative stress.
- Participants taking supplements that decrease oxidative stress or inflammatory markers
- Participants with hypersensitivity to alpha lipoic acid
- Participants who are non-compliant.
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 acidAlso: Thioctic AcidTHIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA | Drug | (Alpha lipoic acid) Active Group |
| PlaceboPlacebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid. | Other | (Placebo) Control Group |
Primary outcome
Serum level of E-Selectin
Time frame: at baseline and after the duration of treatment (6 months)
The effect of ALA supplementation on the serum level of E-Selectin in pediatric patients on regular hemodialysis.
3 secondary outcomes
Serum levels of superoxide dismutase (SOD)
Time frame: at baseline and after the duration of treatment (6 months)
Number of cardiovascular events
Time frame: for the duration of treatment (6 months)
Number of Adverse effects
Time frame: for the duration of treatment (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 33086555Fogacci F, Rizzo M, Krogager C, Kennedy C, Georges CMG, Knezevic T, Liberopoulos E, Vallee A, Perez-Martinez P, Wenstedt EFE, Satrauskiene A, Vrablik M, Cicero AFG. Safety Evaluation of alpha-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies. Antioxidants (Basel). 2020 Oct 19;9(10):1011. doi: 10.3390/antiox9101011.
- Background: PubMed 30721699Haghighatdoost F, Hariri M. The effect of alpha-lipoic acid on inflammatory mediators: a systematic review and meta-analysis on randomized clinical trials. Eur J Pharmacol. 2019 Apr 15;849:115-123. doi: 10.1016/j.ejphar.2019.01.065. Epub 2019 Feb 2.
- Background: PubMed 18221433Huang EA, Gitelman SE. The effect of oral alpha-lipoic acid on oxidative stress in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2008 Jun;9(3 Pt 2):69-73. doi: 10.1111/j.1399-5448.2007.00342.x. Epub 2008 Jan 22.
- Background: PubMed 37124791Li LC, Tain YL, Kuo HC, Hsu CN. Cardiovascular diseases morbidity and mortality among children, adolescents and young adults with dialysis therapy. Front Public Health. 2023 Apr 12;11:1142414. doi: 10.3389/fpubh.2023.1142414. eCollection 2023.
- Background: PubMed 17875185Malatino LS, Stancanelli B, Cataliotti A, Bellanuova I, Fatuzzo P, Rapisarda F, Leonardis D, Tripepi G, Mallamaci F, Zoccali C. Circulating E-selectin as a risk marker in patients with end-stage renal disease. J Intern Med. 2007 Oct;262(4):479-87. doi: 10.1111/j.1365-2796.2007.01841.x.
- Background: PubMed 33376686Al-Nami MS, Al-Kuraishy HM, Al-Gareeb AI. Impact of thioctic acid on glycemic indices and associated inflammatory-induced endothelial dysfunction in patients with type 2 diabetes mellitus: A case control study. Int J Crit Illn Inj Sci. 2020 Sep;10(Suppl 1):21-27. doi: 10.4103/IJCIIS.IJCIIS_62_19. Epub 2020 Sep 16.
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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.
Mahmoud Mohsen, Pharmacist principal investigator
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha lipoic acid in people with Hemodialysis Complication and Pediatric Kidney Disease, run by Ain Shams University 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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 2 Mar 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Serum level of E-Selectin (time frame: at baseline and after the duration of treatment (6 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 NCT06286098, which also lists 6 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 2 Mar 2026.