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Biotin Deficiency and Restless Legs Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02011191
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Saint Patrick Hospital
University of Arkansas
Information provided by (Responsible Party):
Heidi Moretti, MS, RD, Saint Patrick Hospital

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Restless Legs Syndrome Dietary Supplement: Biotin Supplementation Dietary Supplement: Sugar Pill Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Biotin Deficiency and Restless Legs Syndrome: Evidence for a Causal Relationship From Randomized, Double-Blind, Placebo-Controlled Trial
Study Start Date : December 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Active Comparator: Biotin
10,000 micrograms biotin daily for 8 weeks
Dietary Supplement: Biotin Supplementation
10,000 micrograms biotin supplement daily for 8 weeks
Other Name: Biotin, Hillestad Pharmeceuticals

Placebo Comparator: Sugar pill Dietary Supplement: Sugar Pill
Identical sugar pill, identical bottle as the biotin supplementation group
Other Name: Hillestad Pharmeceuticals

Primary Outcome Measures :
  1. Biotin Status of Dialysis Patients [ Time Frame: 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.

  2. Change in Restless Legs Syndrome (RLS) symptoms after Biotin treatment [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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}.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02011191

Sponsors and Collaborators
Heidi Moretti, MS, RD
Saint Patrick Hospital
University of Arkansas
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Principal Investigator: John Lakatua, MD Saint Patrick Hospital
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Responsible Party: Heidi Moretti, MS, RD, Clinical Dietitian, Saint Patrick Hospital Identifier: NCT02011191    
Other Study ID Numbers: NIH DK 36823-28
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013
Keywords provided by Heidi Moretti, MS, RD, Saint Patrick Hospital:
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Kidney Failure, Chronic
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs