Biotin Deficiency and Restless Legs Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.

Official Title
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Biotin Deficiency and Restless Legs Syndrome: Evidence for a Causal Relationship From Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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End Stage Renal Disease, Restless Legs Syndrome

Intervention / Treatment
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* Dietary Supplement: Biotin Supplementation
* Dietary Supplement: Sugar Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ESRD requiring hemodialysis or peritoneal dialysis therapy for a duration of at least 3 months. Exclusion Criteria: History of consumption of more than 300 micrograms daily of biotin Oral contraceptive therapy containing high amounts of estrogen because studies in rats provide evidence that high doses of steroid hormones reduce biotin status {Wang, 1997 #1634} Women of childbearing age because of concern that biotin deficiency may be teratogenic {Mock, 2009 #2568}.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biotin<br>10,000 micrograms biotin daily for 8 weeks | Dietary Supplement: Biotin Supplementation<br>* 10,000 micrograms biotin supplement daily for 8 weeks<br>* Other names: Biotin, Hillestad Pharmeceuticals;|
| Placebo Comparator: Sugar pill<br> | Dietary Supplement: Sugar Pill<br>* Identical sugar pill, identical bottle as the biotin supplementation group<br>* Other names: Hillestad Pharmeceuticals;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biotin, Restless, Kidney, Dialysis, Renal