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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02011191

Enrollment

Registered

2013-12-13

Start date

2006-12-31

Completion date

2008-12-31

Last updated

2013-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Restless Legs Syndrome

Keywords

Biotin, Restless, Kidney, Dialysis, Renal

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.

Interventions

DIETARY_SUPPLEMENTBiotin Supplementation

10,000 micrograms biotin supplement daily for 8 weeks

DIETARY_SUPPLEMENTSugar Pill

Identical sugar pill, identical bottle as the biotin supplementation group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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}.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026