Restless Legs SyndromePhase 2/3ShirazUMSNCT01125033
Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients
A Phase 2/3 study testing Vitamin C & Vitamin E, Vitamin C and Vitamin E in people with Restless Legs Syndrome and Kidney Failure, Chronic, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restless Legs Syndrome, Kidney Failure, Chronic
- What is being tested?
- Vitamin C & Vitamin E, Vitamin C and Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Mar 2008to Feb 2009
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who fulfill Restless leg syndrome international criteria(IRLSSG)
- Patients who are stable on HD without any internment illness or admission
Who cannot join
- Patients who have renal stone
- Patients who receive medications with RLS aggravating or alleviating properties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial
The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.
Read the detailed description
RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in hemodialysis patients.
- Conditions
- Restless Legs Syndrome, Kidney Failure, Chronic
- Being tested
- Vitamin C & Vitamin E, Vitamin C, Vitamin E, Vitamin C Placebo & Vitamin E Placebo
- Keywords
- Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E
- Medical subject headings
- Restless Legs Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C & Vitamin EDrug
The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks
Vitamin CDrug
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
Vitamin EDrug
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
Vitamin C Placebo & Vitamin E PlaceboDrug
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C & Vitamin E. | Experimental | The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks Receives: Drug: Vitamin C & Vitamin E |
| Vitamin C & Placebo | Experimental | The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks. Receives: Drug: Vitamin C |
| Vitamin E & Placebo | Experimental | The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks. Receives: Drug: Vitamin E |
| Double Placebo | Placebo comparator | The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks. Receives: Drug: Vitamin C Placebo & Vitamin E Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in IRLS Sum Score
Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population
Measured: 8 Weeks
Secondary outcomes (1)
Number of participants with adverse events
Number of participants with adverse events throughout the treatment phase of the study would be assessed.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionFeb 2009
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 Restless Legs SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Hamideh Akbari, MD, Principal investigator, Shiraz University of Medical SciencesMohammad Mahdi Sagheb, MD, Study chair, Shiraz University of Medical SciencesSahar Sohrabi Nazari, MD, Principal investigator, Shiraz University of Medical SciencesMohammad Kazem Fallahzadeh, MD, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125033
- Sponsor's protocol ID
- 86-3893
- Acronym
- ShirazUMS
- Status last verified
- Jun 2011
- First submitted
- 14 May 2010
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01125033
- Acronym / sponsor ID
- ShirazUMS / 86-3893
- Conditions
- Restless Legs Syndrome, Kidney Failure, Chronic
- Keywords
- Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 May 2010 (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 whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.
Detailed description
RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin C & Vitamin E. | Experimental | Drug: Vitamin C & Vitamin EThe patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks |
| Vitamin C & Placebo | Experimental | Drug: Vitamin CThe patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks. |
| Vitamin E & Placebo | Experimental | Drug: Vitamin EThe patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks. |
| Double Placebo | Placebo comparator | Drug: Vitamin C Placebo & Vitamin E PlaceboThe patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who fulfill Restless leg syndrome international criteria(IRLSSG)
- Patients who are stable on HD without any internment illness or admission
Key exclusion criteria (2 listed)
- Patients who have renal stone
- Patients who receive medications with RLS aggravating or alleviating properties
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 |
|---|---|---|
| Vitamin C & Vitamin EThe patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks | Drug | Vitamin C & Vitamin E. |
| Vitamin CThe patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks. | Drug | Vitamin C & Placebo |
| Vitamin EThe patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks. | Drug | Vitamin E & Placebo |
| Vitamin C Placebo & Vitamin E PlaceboThe patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks. | Drug | Double Placebo |
Primary outcome
Absolute Change in IRLS Sum Score
Time frame: 8 Weeks
Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population
1 secondary outcome
Number of participants with adverse events
Time frame: 8 Weeks
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 17 Jun 2011.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
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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.
Hamideh Akbari, MD principal investigator
Shiraz University of Medical Sciences
Mohammad Mahdi Sagheb, MD study chair
Shiraz University of Medical Sciences
Sahar Sohrabi Nazari, MD principal investigator
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin C & Vitamin E, Vitamin C and Vitamin E in people with Restless Legs Syndrome and Kidney Failure, Chronic, run by Shiraz 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 2 inclusion and 2 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 17 Jun 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. 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 combined 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.
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?
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?
Absolute Change in IRLS Sum Score (time frame: 8 Weeks). 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 NCT01125033, 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 17 Jun 2011.