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Biotin Deficiency and Restless Legs Syndrome

Primary Purpose

End Stage Renal Disease, Restless Legs Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Biotin Supplementation

Sugar Pill

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Biotin, Restless, Kidney, Dialysis, Renal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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}.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Biotin

Sugar pill

Arm Description

10,000 micrograms biotin daily for 8 weeks

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02011191

First Posted

January 3, 2012

Last Updated

December 12, 2013

Sponsor

Heidi Moretti, MS, RD

Collaborators

Saint Patrick Hospital, University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT02011191

Brief Title

Biotin Deficiency and Restless Legs Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Heidi Moretti, MS, RD

Collaborators

Saint Patrick Hospital, University of Arkansas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Restless Legs Syndrome

Keywords

Biotin, Restless, Kidney, Dialysis, Renal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biotin

Arm Type

Active Comparator

Arm Description

10,000 micrograms biotin daily for 8 weeks

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Biotin Supplementation

Other Intervention Name(s)

Biotin, Hillestad Pharmeceuticals

Intervention Description

10,000 micrograms biotin supplement daily for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Sugar Pill

Other Intervention Name(s)

Hillestad Pharmeceuticals

Intervention Description

Identical sugar pill, identical bottle as the biotin supplementation group

Primary Outcome Measure Information:

Title

Biotin Status of Dialysis Patients

Description

Time Frame

Measurement at baseline and after 8 weeks of treatment

Title

Change in Restless Legs Syndrome (RLS) symptoms after Biotin treatment

Description

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.

Time Frame

Baseline RLS score measurement and measurement after 8 weeks of treatment

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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}.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Lakatua, MD

Organizational Affiliation

Saint Patrick Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Biotin Deficiency and Restless Legs Syndrome

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