Biotin Deficiency and Restless Legs Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome; End Stage Renal Disease
• Intervention / Treatment: Dietary supplement: Biotin Supplementation; Dietary supplement: Sugar Pill

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heidi Moretti, MS, RD
• Collaborators: University of Arkansas; Saint Patrick Hospital
• Investigators: Principal Investigator: John Lakatua, MD, Saint Patrick Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Dialysis; Kidney; Renal; Biotin; Restless
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Renal Insufficiency; Dyskinesias; Psychomotor Disorders; Parasomnias; Renal Insufficiency, Chronic; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Kidney Failure, Chronic; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Biotin
• Other Study ID Numbers: NIH DK 36823-28