Biotin Deficiency and Restless Legs Syndrome

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011191
• Other study ID #: NIH DK 36823-28
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: December 12, 2013
• Start date: December 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2013
• Source: Saint Patrick Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biotinidase Deficiency
• End Stage Renal Disease
• Kidney Failure, Chronic
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Biotin Supplementation
10,000 micrograms biotin supplement daily for 8 weeks
• Sugar Pill
Identical sugar pill, identical bottle as the biotin supplementation group

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Heidi Moretti, MS, RD	Saint Patrick Hospital, University of Arkansas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No