Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess changes, if any, in measures of self-assessed well-being attributable to paricalcitol after RYGB. Evaluate the rates of hypercalcemia, kidney stones, gastrointestinal side effects, and other organ system adverse effects of paricalcitol, cholecalciferol, and placebo in patients after RYGB
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
1 microgram by mouth daily for 6 weeks
5000 IU (international units) by mouth daily for 6 weeks
Inactive substance, one capsule daily for 6 weeks
William Beaumont Health Center
Royal Oak, Michigan, United States
The Primary Outcome Measure With iPTH
Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study
Time frame: 6 weeks
Alkaline Phosphatase
This secondary outcome measure is change in alkaline phosphatase from baseline to final measure at 6 weeks differences were compared between the 3 arms of the study
Time frame: 6 weeks
Serum Calcium
This secondary outcome measure is change in serum calcium from baseline to final measure at 6 weeks differences in the 3 arms were compared
Time frame: 6 weeks
Serum 25 OH Vitamin D
This secondary outcome measure is change in serum hydroxy-vitaminD from baseline to final measure at 6 weeks differences in the 3 arms were compared
Time frame: 6 weeks
Serum Phosphorus
This secondary outcome measure is change in serum phosphorus from baseline to final measure at 6 weeks differences in the 3 arms were compared
Time frame: 6 weeks
Osteocalcin
This secondary outcome measure is change in osteocalcin from baseline to final measure at 6 weeks differences in the 3 arms were compared
Time frame: 6 weeks
N-Telopeptide Cross Linked Urine
This secondary outcome measure is change in N-Telopeptide cross linked urine from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Time frame: 6 weeks
Bone Specific Alkaline Phosphatase
This secondary outcome measure is change in bone specific alkaline phosphatase from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Time frame: 6 weeks
24 Hour Urine Calcium
This secondary outcome measure is change in 24-hour urine calcium from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.