NCT02011191

Biotin Deficiency and Restless Legs Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Heidi Moretti, MS, RD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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

Conditions

• End Stage Renal Disease
• Restless Legs Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Biotin Supplementation	10,000 micrograms biotin supplement daily for 8 weeks
DIETARY_SUPPLEMENT	Sugar Pill	Identical sugar pill, identical bottle as the biotin supplementation group

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-12-01
• Completion: 2008-12-01
• First posted: 2013-12-13
• Last updated: 2013-12-13