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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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. |
|
| Double Placebo | Placebo Comparator | The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C & Vitamin E | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number of participants with adverse events throughout the treatment phase of the study would be assessed. | 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamideh Akbari, MD | Shiraz University of Medical Sciences | Principal Investigator |
| Mohammad Mahdi Sagheb, MD | Shiraz University of Medical Sciences | Study Chair |
| Sahar Sohrabi Nazari, MD | Shiraz University of Medical Sciences | Principal Investigator |
| Mohammad Kazem Fallahzadeh, MD | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiraz University of Medical Sciences | Shiraz | Fars | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37916745 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 20, 2011 | |
| Reset | Jul 15, 2011 | |
| Release | Jul 19, 2011 |
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| Vitamin C | Drug | The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks. |
|
| Vitamin E | Drug | 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 Placebo | Drug | The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks. |
|
| Reset | Aug 16, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 20, 2011 | Jul 15, 2011 | |||
| Jul 19, 2011 | Aug 16, 2011 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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