Trial | NCT02011191  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    biotin ...

  • Study Participants

    49
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.
Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.
Study Started
Dec 31
2006
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2008
Last Update
Dec 13
2013
Estimate

Dietary Supplement Biotin Supplementation

10,000 micrograms biotin supplement daily for 8 weeks

  • Other names: Biotin, Hillestad Pharmeceuticals

Dietary Supplement Sugar Pill

Identical sugar pill, identical bottle as the biotin supplementation group

  • Other names: Hillestad Pharmeceuticals

Biotin Active Comparator

10,000 micrograms biotin daily for 8 weeks

Sugar pill Placebo Comparator

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}.
No Results Posted