CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 49 enrolled
Drug / intervention
Paricalcitol +2 moredrug
Likely dose
Paricalcitol 1 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01138475
NCT01138475Phase 3Completed
CompareCT.gov

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

Kerstyn C. Zalesin, M.D.·interventional·Posted Jun 7, 2010·Updated Mar 22, 2017

In Brief

A Phase 3 clinical trial evaluating Paricalcitol, Cholecalciferol, and 1 other intervention for Gastric Bypass and Parathyroid Hormone. Completed, enrolled 49 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Bypass, Parathyroid Hormone
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 16.1 years ago

Interventions

Paricalcitoldrug

1 microgram by mouth daily for 6 weeks

Cholecalciferoldrug

5000 IU (international units) by mouth daily for 6 weeks

Placebodrug

Inactive substance, one capsule daily for 6 weeks