Trial record 2 of 2 for:    "biotinidase deficiency"

Biotin Deficiency and Restless Legs Syndrome

This study has been completed.
Sponsor:
Collaborators:
Saint Patrick Hospital
University of Arkansas
Information provided by (Responsible Party):
Heidi Moretti, MS, RD, Saint Patrick Hospital
ClinicalTrials.gov Identifier:
NCT02011191
First received: January 3, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
End Stage Renal Disease
Restless Legs Syndrome
Dietary Supplement: Biotin Supplementation
Dietary Supplement: Sugar Pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Biotin Deficiency and Restless Legs Syndrome: Evidence for a Causal Relationship From Randomized, Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Saint Patrick Hospital:

Primary Outcome Measures:
  • Biotin Status of Dialysis Patients [ Time Frame: Measurement at baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline RLS score measurement and measurement after 8 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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}.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011191

Sponsors and Collaborators
Heidi Moretti, MS, RD
Saint Patrick Hospital
University of Arkansas
Investigators
Principal Investigator: John Lakatua, MD Saint Patrick Hospital
  More Information

No publications provided

Responsible Party: Heidi Moretti, MS, RD, Clinical Dietitian, Saint Patrick Hospital
ClinicalTrials.gov Identifier: NCT02011191     History of Changes
Other Study ID Numbers: NIH DK 36823-28
Study First Received: January 3, 2012
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Patrick Hospital:
Biotin
Restless
Kidney
Dialysis
Renal

Additional relevant MeSH terms:
Biotinidase Deficiency
Kidney Diseases
Kidney Failure, Chronic
Restless Legs Syndrome
Psychomotor Agitation
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Multiple Carboxylase Deficiency
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolic Diseases
Biotin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014