Biotin Deficiency and Restless Legs Syndrome

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.

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Key information

Conditions

End Stage Renal Disease Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Chronic Disease Disease Attributes Dyskinesias Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Renal Insufficiency Renal Insufficiency, Chronic Restless Legs Syndrome Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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}.

Treatment and study plan

Biotin Supplementation

Dietary Supplement

10,000 micrograms biotin supplement daily for 8 weeks

Other names: Biotin, Hillestad Pharmeceuticals

Sugar Pill

Dietary Supplement

Identical sugar pill, identical bottle as the biotin supplementation group

Other names: Hillestad Pharmeceuticals

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Heidi Moretti, MS, RD

Other

Collaborators

Saint Patrick Hospital
University of Arkansas

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: Dec 13, 2013
Registry last updated: Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed