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Bone Mass and Strength After Kidney Transplantation

NCT02224144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-03-07

Study results available
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Summary

The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.

Conditions

Interventions

DRUG

Vitamin D3

Vitamin D3 1000 IU per day for 12 months

DRUG

Calcitriol

Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months

DRUG

Placebo

Placebo (sugar pill) 1 pill per day for 12 months

Sponsors & Collaborators

Principal Investigators

  • Thomas Nickolas, MD, MS · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-18
Primary Completion
2016-10-12
Completion
2016-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT02224144 on ClinicalTrials.gov