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

NCT01138475 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-03-22

Study results available
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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

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

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Kerstyn C. Zalesin, M.D.

    lead OTHER

Principal Investigators

  • Kerstyn Zalesin, MD · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138475 on ClinicalTrials.gov