NCT01138475

Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery

A Prospective, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Pilot Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Kerstyn C. Zalesin, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Gastric Bypass
• Parathyroid Hormone

Interventions

Type	Name	Description
DRUG	Paricalcitol	1 microgram by mouth daily for 6 weeks
DRUG	Cholecalciferol	5000 IU (international units) by mouth daily for 6 weeks
DRUG	Placebo	Inactive substance, one capsule daily for 6 weeks

Timeline

• Start date: 2010-07-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-06-07
• Last updated: 2017-03-22
• Results posted: 2017-03-22

Locations

1 site across 1 country: United States