Clinical Trial: Biotin Deficiency and Restless Legs Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Biotin Deficiency and Restless Legs Syndrome: Evidence for a Causal Relationship From Randomized, Double-Blind, Placebo-Controlled Trial
Brief Summary: 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 Summary: Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.
Sponsor: Heidi Moretti, MS, RD
Current Primary Outcome:
- Biotin Status of Dialysis Patients [ Time Frame: Measurement at baseline and after 8 weeks of treatment ]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.
- Change in Restless Legs Syndrome (RLS) symptoms after Biotin treatment [ Time Frame: Baseline RLS score measurement and measurement after 8 weeks of 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Saint Patrick Hospital
Dates:
Date Received: January 3, 2012
Date Started: December 2006
Date Completion:
Last Updated: December 12, 2013
Last Verified: December 2013
