12
Participants
Start Date
January 1, 2016
Primary Completion Date
June 1, 2016
Study Completion Date
December 31, 2019
BH4
BH4 10 mg/kg/day given once to a total of 12 SSc patients
Vasculopathy assessment
Non-invasive technique, flow mediated dilatation (FMD) to define vasculopathy in SSc.
Placebo
On the experimental days, patients reported to the laboratory after having consumed a standardized breakfast and oral BH4 (10mg/kg) or placebo five hours prior to their arrival. All measurements were taken at the same time of day to eliminate any diurnal effects. All participants abstained from alcohol, caffeine, and exercise for ≥12 hours prior to the study. Additionally, vasodilatory medications were discontinued 12 hours prior to study visit. In premenopausal women, measurements were performed during the early follicular phase of the menstrual cycle. All measurements were made under quiet, comfortable, ambient (\~22°C) laboratory conditions.
VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City
VA Office of Research and Development
FED