Complication of HemodialysisPhase 2NCT01278693
Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients
A Phase 2 study testing L-carnitine in people with Complication of Hemodialysis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complication of Hemodialysis
- What is being tested?
- L-carnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIran
- Study dates
- Aug 2009to Sep 2010
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration >200 mg/dl or serum HDL concentration >40 mg/dl in the beginning of the study.
Who cannot join
- taking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Treatment of Dyslipidemia for Hemodialysis
The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.
Read the detailed description
In patients under maintenance hemodialysis several factors reduce the body stored carnitine which in turn affected dyslipidemia, anemia, and general health in these patients. The investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life in hemodialysis patients.
- Conditions
- Complication of Hemodialysis
- Being tested
- L-carnitine, placebo
- Keywords
- Renal failure, hemodialysis, dyslipidemia, L-carnitine.
- Medical subject headings
- Renal Insufficiency, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDrug
500 mg,twice daily, 16 weeks
placeboDrug
500 mg,twice daily, 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Other | it is as like as L-carnitine in shape Receives: Drug: placebo |
| L-carnitine | Other | it is kind of supplement Receives: Drug: L-carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid profile
Measured: at sixteen weeks after admission
Secondary outcomes (2)
anemia
Measured: at sixteen weeks after admission
quality of life
Measured: at sixteen weeks after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of HemodialysisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mahnaz Moradi, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278693
- Sponsor's protocol ID
- ASD-1213-11
- Status last verified
- Aug 2009
- First submitted
- 18 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.
PubMed 36472884
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Treatment of Dyslipidemia for Hemodialysis
- ClinicalTrials.gov ID
- NCT01278693
- Acronym / sponsor ID
- ASD-1213-11
- Conditions
- Complication of Hemodialysis
- Keywords
- Renal failure, hemodialysis, dyslipidemia, L-carnitine.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Jan 2011 (estimated)
- 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 purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.
Detailed description
In patients under maintenance hemodialysis several factors reduce the body stored carnitine which in turn affected dyslipidemia, anemia, and general health in these patients. The investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Other | Drug: placeboit is as like as L-carnitine in shape |
| L-carnitine | Other | Drug: L-carnitineit is kind of supplement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- being in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration >200 mg/dl or serum HDL concentration >40 mg/dl in the beginning of the study.
Key exclusion criteria (1 listed)
- taking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.
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-carnitine500 mg,twice daily, 16 weeks | Drug | L-carnitine |
| placebo500 mg,twice daily, 16 weeks. | Drug | placebo |
Primary outcome
lipid profile
Time frame: at sixteen weeks after admission
2 secondary outcomes
anemia
Time frame: at sixteen weeks after admission
quality of life
Time frame: at sixteen weeks after admission
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 Jan 2011.
- Derived from this study: PubMed 36472884Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.
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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.
Mahnaz Moradi, MD study chair
MD,research comittee
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 in people with Complication of Hemodialysis, run by Isfahan University of Medical Sciences 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 1 inclusion and 1 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 Jan 2011. 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. 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?
lipid profile (time frame: at sixteen weeks after admission). 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 NCT01278693, which also lists 1 linked publication.
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 Jan 2011.