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Biotin Deficiency and Restless Legs Syndrome

NCT02011191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-12-13

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Biotin Supplementation

10,000 micrograms biotin supplement daily for 8 weeks

DIETARY_SUPPLEMENT

Sugar Pill

Identical sugar pill, identical bottle as the biotin supplementation group

Sponsors & Collaborators

  • Saint Patrick Hospital

    collaborator OTHER

  • University of Arkansas

    collaborator OTHER

  • Heidi Moretti, MS, RD

    lead OTHER

Principal Investigators

  • John Lakatua, MD · Saint Patrick Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-12-31
Completion
2008-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011191 on ClinicalTrials.gov