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Biotin Deficiency and Restless Legs Syndrome

NCT ID: NCT02011191

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-12-31

Brief Summary

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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

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

Conditions

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End Stage Renal Disease Restless Legs Syndrome

Keywords

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Biotin Restless Kidney Dialysis Renal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Biotin

10,000 micrograms biotin daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Biotin Supplementation

Intervention Type DIETARY_SUPPLEMENT

10,000 micrograms biotin supplement daily for 8 weeks

Sugar pill

Group Type PLACEBO_COMPARATOR

Sugar Pill

Intervention Type DIETARY_SUPPLEMENT

Identical sugar pill, identical bottle as the biotin supplementation group

Interventions

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Biotin Supplementation

10,000 micrograms biotin supplement daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Sugar Pill

Identical sugar pill, identical bottle as the biotin supplementation group

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Biotin, Hillestad Pharmeceuticals Hillestad Pharmeceuticals

Eligibility Criteria

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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}.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Patrick Hospital

OTHER

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role collaborator

Heidi Moretti, MS, RD

OTHER

Sponsor Role lead

Responsible Party

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Heidi Moretti, MS, RD

Clinical Dietitian

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John Lakatua, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Patrick Hospital

Other Identifiers

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NIH DK 36823-28

Identifier Type: -

Identifier Source: org_study_id