Biotin Deficiency and Restless Legs Syndrome

Heidi Moretti, MS, RD

Status

Completed

Conditions

End Stage Renal Disease

Restless Legs Syndrome

Treatments

Dietary Supplement: Biotin Supplementation

Dietary Supplement: Sugar Pill

Study type

Interventional

Funder types

Other

Identifiers

NCT02011191

NIH DK 36823-28

Details and patient eligibility

About

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.

Full description

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

Enrollment

49 patients

Sex

All

Volunteers

No Healthy Volunteers

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}.