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| Name | Class |
|---|---|
| Saint Patrick Hospital | OTHER |
| University of Arkansas | OTHER |
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Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of biotin deficiency in those with and without RLS (Study 1) and to determine the effect of biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due to ESRD.
Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotin | Active Comparator | 10,000 micrograms biotin daily for 8 weeks |
|
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotin Supplementation | Dietary Supplement | 10,000 micrograms biotin supplement daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biotin Status of Dialysis Patients | Biotin status is measured using Propionyl CoA carboxylase and Propionyl CoA carboxylase activation coefficients that are from isolated lymphocyte samples. This is a measurement that is independent of kidney function. | Measurement at baseline and after 8 weeks of treatment |
| Change in Restless Legs Syndrome (RLS) symptoms after Biotin treatment | The RLS is measured using the International Restless Legs Syndrome Scale, a validated tool for assessing severity of RLS in patient who have been diagnosed with RLS. | Baseline RLS score measurement and measurement after 8 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lakatua, MD | Saint Patrick Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D012148 | Restless Legs Syndrome |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D001710 | Biotin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sugar Pill | Dietary Supplement | Identical sugar pill, identical bottle as the biotin supplementation group |
|
|
| 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 |
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002241 | Carbohydrates |