drugset / Trial / NCT01138475

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

NCT01138475

Phase 3 Completed 49 enrolled Kerstyn C. Zalesin, M.D. Abbott · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2010-07
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cholecalciferol Other / unclassified 5000 iu Oral
Comparator Paricalcitol Other / unclassified 1 ug Oral