Biotin Deficiency and Restless Legs Syndrome

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Restless Legs Syndrome
• Interventions: Dietary Supplement: Biotin Supplementation; Dietary Supplement: Sugar Pill

• Registration Number: NCT02011191
• Lead Sponsor: Heidi Moretti, MS, RD

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 Description

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

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-12
• Study Completion: 2008-12
• Study First Submitted: 2012-01-03
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-13
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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}.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biotin	Biotin Supplementation	10,000 micrograms biotin daily for 8 weeks
Sugar pill	Sugar Pill	-

Primary Outcome Measures

Name	Time	Method
Biotin Status of Dialysis Patients	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	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.