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
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Biotin, Restless, Kidney, Dialysis, Renal
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}.
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
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.
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
No
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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