Biotin Deficiency and Restless Legs Syndrome

NCT02011191 | Completed DMC

• 1 other identifier: NIH DK 36823-28
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease; Restless Legs Syndrome

Keywords

Biotin; Restless; Kidney; Dialysis; Renal

Outcome Measures

Primary Outcomes (2)

• 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.

  Measurement at baseline and after 8 weeks of treatment

• 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.

  Baseline RLS score measurement and measurement after 8 weeks of treatment

Study Arms (2)

Biotin

ACTIVE COMPARATOR

10,000 micrograms biotin daily for 8 weeks

Dietary Supplement: Biotin Supplementation

Sugar pill

PLACEBO COMPARATOR

Dietary Supplement: Sugar Pill

Interventions

Biotin Supplementation DIETARY_SUPPLEMENT

10,000 micrograms biotin supplement daily for 8 weeks

Also known as: Biotin, Hillestad Pharmeceuticals

Biotin

Sugar Pill DIETARY_SUPPLEMENT

Identical sugar pill, identical bottle as the biotin supplementation group

Also known as: Hillestad Pharmeceuticals

Sugar pill

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ESRD requiring hemodialysis or peritoneal dialysis therapy for a duration of at least 3 months.

You may not qualify if:

• 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}.

Sponsors & Collaborators

• Heidi Moretti, MS, RD: lead
• Saint Patrick Hospital: collaborator
• University of Arkansas: collaborator

MeSH Terms

Conditions

Kidney Failure, Chronic; Restless Legs Syndrome; Psychomotor Agitation

Interventions

Biotin; Sugars

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Carbohydrates

Study Officials

• John Lakatua, MD

  Saint Patrick Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Dietitian

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: December 13, 2013
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: December 13, 2013

Record last verified: 2013-12