End-stage Renal Disease (ESRD)Phase 2NCT07249229
Oral L-carnitine and Inflammatory and Nutritional Biomarkers in Maintenance Hemodialysis
A Phase 2 study testing L-carnitine 1000 Mg in people with End-stage Renal Disease (ESRD) and Hemodialysis, run by Darya Chamani at 1 site in Iran.
Trial summary
The goal of this clinical trial is to evaluate whether oral L-carnitine supplementation helps reduce inflammation and improve nutritional status in patients with end-stage kidney disease who are undergoing long-term hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD), Hemodialysis
- What is being tested?
- L-carnitine 1000 Mg
- 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 siteIran
- Study dates
- 30 Nov 2020to 8 Mar 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- On maintenance hemodialysis for at least 6 months
- Clinically stable for ≥ 3 months
- No hospitalization in the preceding 3 months
- Willingness to provide written informed consent and comply with study procedures
Who cannot join
- Use of statins, erythropoietin, corticosteroids, NSAIDs, or other anti-inflammatory/lipid-lowering agents within the previous 3 months
- Active infection, inflammatory disease, malignancy, or severe hepatic dysfunction
- Pregnancy or breastfeeding
- Participation in another clinical trial within the preceding 3 months
- Uncontrolled comorbidities (e.g., uncontrolled diabetes or hypertension)
- Acute cardiovascular events within the past 6 months
Show all 10Show fewer
- Planned kidney transplantation during the study period
- Anticipated poor compliance
- Use of medications that could affect inflammatory or lipid parameters
- History of hypersensitivity to L-carnitine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Oral L-Carnitine on Inflammatory and Nutritional Factors in Patients With Advanced Kidney Failure Undergoing Chronic Hemodialysis
The goal of this clinical trial is to evaluate whether oral L-carnitine supplementation helps reduce inflammation and improve nutritional status in patients with end-stage kidney disease who are undergoing long-term hemodialysis.
A total of 50 participants will be randomly assigned to receive either:
Read more
- Oral L-carnitine solution (1 g, three times per week after dialysis), or
- A placebo solution that looks and tastes the same but does not contain L-carnitine.
The study will last for three months. Researchers will assess changes in:
- Inflammatory markers (high-sensitivity C-reactive protein, hs-CRP)
- Nutritional markers (serum albumin, ferritin)
- Blood lipid profile (cholesterol, LDL, HDL, triglycerides)
The findings from this study are expected to provide insights into the potential clinical benefits of oral L-carnitine supplementation in maintenance hemodialysis patients.
Read the detailed description
This randomized, quadruple-blind, placebo-controlled clinical trial is designed to investigate the effect of oral L-carnitine supplementation on inflammatory and nutritional parameters in patients with end-stage renal disease (ESRD) undergoing chronic hemodialysis (HD).
Study Design and Participants:
The study is conducted at the dialysis departments of Bu Ali Hospital and Partian Clinic in Tehran. Eligible participants are adults (≥18 years) who have been on maintenance HD for at least 6 months, are clinically stable for at least 3 months, and are able to provide informed consent. Patients are excluded if they have a recent infection, malignancy, severe liver disease, uncontrolled comorbidities, or have used anti-inflammatory or lipid-lowering drugs within the previous 3 months.
Randomization and Intervention:
Fifty participants are randomized into two groups. The intervention group receives oral L-carnitine solution (1 g, three times per week after dialysis, produced by Bonyan Salamat Kasra Company). The control group receives a placebo solution (distilled water with sodium saccharin) identical in appearance and packaging. Randomization is computer-generated and allocation is concealed.
Endpoints:
The primary outcome measure is the change in high-sensitivity C-reactive protein (hs-CRP) after three months of intervention. Secondary outcome measures include changes in serum albumin, ferritin, triglycerides, total cholesterol, HDL, and LDL.
This study is intended to help determine whether oral L-carnitine supplementation can improve inflammation, nutritional status, and lipid metabolism in hemodialysis patients.
- Conditions
- End-stage Renal Disease (ESRD), Hemodialysis
- Being tested
- L-carnitine 1000 Mg, Placebo
- Keywords
- L-carnitine, Hemodialysis, End-stage renal disease, Inflammation, Malnutrition, hs-CRP, Albumin, Ferritin, Lipid profile
- Medical subject headings
- Kidney Failure, Chronic, Inflammation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine 1000 MgDrug
Participants assigned to the intervention arm received L-carnitine oral solution (1 g) administered three times per week immediately after each hemodialysis session for a total duration of 3 months.
The oral solution was provided in identical packaging and labeling as placebo to ensure double blinding.
PlaceboDrug
Participants assigned to the placebo arm received an oral placebo solution consisting of distilled water and sodium saccharin, three times weekly immediately post-hemodialysis for 3 months, matched to the active formulation in appearance, packaging, and labeling.
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine Group | Experimental | Patients received oral L-carnitine solution (1 g), administered three times per week immediately after each hemodialysis session for 3 months. Receives: Drug: L-carnitine 1000 Mg |
| Placebo Group | Placebo comparator | Patients received placebo solution (distilled water and sodium saccharin), identical in appearance, packaging, and labeling to the active formulation, administered three times per week immediately after each hemodialysis session for 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-CRP levels (high sensitivity C-reactive protein)
Change in serum hs-CRP levels from baseline to 3 months of treatment. hs-CRP will be measured to evaluate systemic inflammation and assess the anti-inflammatory effect of oral L-carnitine supplementation compared with placebo in patients undergoing hemodialysis
Measured: Baseline and at 3 months after the start of intervention
Secondary outcomes (3)
Lipid profile (total cholesterol, LDL, HDL, triglycerides)
Change in lipid profile parameters from baseline to 3 months to assess metabolic impact of L-carnitine
Measured: Baseline and at 3 months after the start of intervention
Ferritin levels
Change in serum ferritin levels from baseline to 3 months as a marker of iron status and inflammation
Measured: Baseline and at 3 months after the start of intervention
Serum albumin levels
Change in serum albumin concentration from baseline to 3 months as an indicator of nutritional status
Measured: Baseline and at 3 months after the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start30 Nov 2020
- Primary completion28 Feb 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal Disease (ESRD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darya Chamani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darya Chamani, Tehran Islamic Azad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249229
- Sponsor's protocol ID
- LC-HD-IAU-2020
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient privacy concerns, ethical considerations, and institutional restrictions. Only aggregated results will be published in peer-reviewed journals
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Oral L-Carnitine on Inflammatory and Nutritional Factors in Patients With Advanced Kidney Failure Undergoing Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT07249229
- Acronym / sponsor ID
- LC-HD-IAU-2020
- Conditions
- End-stage Renal Disease (ESRD), Hemodialysis
- Keywords
- L-carnitine, Hemodialysis, End-stage renal disease, Inflammation, Malnutrition, hs-CRP, Albumin, Ferritin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Darya ChamaniUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 25 Nov 2025 (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 evaluate whether oral L-carnitine supplementation helps reduce inflammation and improve nutritional status in patients with end-stage kidney disease who are undergoing long-term hemodialysis.
A total of 50 participants will be randomly assigned to receive either:
- Oral L-carnitine solution (1 g, three times per week after dialysis), or
- A placebo solution that looks and tastes the same but does not contain L-carnitine.
The study will last for three months. Researchers will assess changes in:
- Inflammatory markers (high-sensitivity C-reactive protein, hs-CRP)
- Nutritional markers (serum albumin, ferritin)
- Blood lipid profile (cholesterol, LDL, HDL, triglycerides)
The findings from this study are expected to provide insights into the potential clinical benefits of oral L-carnitine supplementation in maintenance hemodialysis patients.
Detailed description
This randomized, quadruple-blind, placebo-controlled clinical trial is designed to investigate the effect of oral L-carnitine supplementation on inflammatory and nutritional parameters in patients with end-stage renal disease (ESRD) undergoing chronic hemodialysis (HD).
Study Design and Participants:
The study is conducted at the dialysis departments of Bu Ali Hospital and Partian Clinic in Tehran. Eligible participants are adults (≥18 years) who have been on maintenance HD for at least 6 months, are clinically stable for at least 3 months, and are able to provide informed consent. Patients are excluded if they have a recent infection, malignancy, severe liver disease, uncontrolled comorbidities, or have used anti-inflammatory or lipid-lowering drugs within the previous 3 months.
Randomization and Intervention:
Fifty participants are randomized into two groups. The intervention group receives oral L-carnitine solution (1 g, three times per week after dialysis, produced by Bonyan Salamat Kasra Company). The control group receives a placebo solution (distilled water with sodium saccharin) identical in appearance and packaging. Randomization is computer-generated and allocation is concealed.
Endpoints:
The primary outcome measure is the change in high-sensitivity C-reactive protein (hs-CRP) after three months of intervention. Secondary outcome measures include changes in serum albumin, ferritin, triglycerides, total cholesterol, HDL, and LDL.
This study is intended to help determine whether oral L-carnitine supplementation can improve inflammation, nutritional status, and lipid metabolism in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-carnitine Group | Experimental | Drug: L-carnitine 1000 MgPatients received oral L-carnitine solution (1 g), administered three times per week immediately after each hemodialysis session for 3 months. |
| Placebo Group | Placebo comparator | Drug: PlaceboPatients received placebo solution (distilled water and sodium saccharin), identical in appearance, packaging, and labeling to the active formulation, administered three times per week immediately after each hemodialysis session for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- On maintenance hemodialysis for at least 6 months
- Clinically stable for ≥ 3 months
- No hospitalization in the preceding 3 months
- Willingness to provide written informed consent and comply with study procedures
Key exclusion criteria (10 listed)
- Use of statins, erythropoietin, corticosteroids, NSAIDs, or other anti-inflammatory/lipid-lowering agents within the previous 3 months
- Active infection, inflammatory disease, malignancy, or severe hepatic dysfunction
- Pregnancy or breastfeeding
- Participation in another clinical trial within the preceding 3 months
- Uncontrolled comorbidities (e.g., uncontrolled diabetes or hypertension)
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 |
|---|---|---|
| L-carnitine 1000 MgParticipants assigned to the intervention arm received L-carnitine oral solution (1 g) administered three times per week immediately after each hemodialysis session for a total duration of 3 months. The oral solution was provided in identical packaging and labeling as placebo to ensure double blinding. | Drug | L-carnitine Group |
| PlaceboParticipants assigned to the placebo arm received an oral placebo solution consisting of distilled water and sodium saccharin, three times weekly immediately post-hemodialysis for 3 months, matched to the active formulation in appearance, packaging, and labeling. | Drug | Placebo Group |
Primary outcome
hs-CRP levels (high sensitivity C-reactive protein)
Time frame: Baseline and at 3 months after the start of intervention
Change in serum hs-CRP levels from baseline to 3 months of treatment. hs-CRP will be measured to evaluate systemic inflammation and assess the anti-inflammatory effect of oral L-carnitine supplementation compared with placebo in patients undergoing hemodialysis
3 secondary outcomes
Lipid profile (total cholesterol, LDL, HDL, triglycerides)
Time frame: Baseline and at 3 months after the start of intervention
Ferritin levels
Time frame: Baseline and at 3 months after the start of intervention
Serum albumin levels
Time frame: Baseline and at 3 months after the start of intervention
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 19 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient privacy concerns, ethical considerations, and institutional restrictions. Only aggregated results will be published in peer-reviewed journals
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-carnitine 1000 Mg in people with End-stage Renal Disease (ESRD) and Hemodialysis, run by Darya Chamani at 1 site in Iran.
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 5 inclusion and 10 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 19 Dec 2025. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
hs-CRP levels (high sensitivity C-reactive protein) (time frame: Baseline and at 3 months after the start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.