Bone Mass and Strength After Kidney Transplantation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-18

Study Completion Date

2016-10-12

Brief Summary

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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.

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Detailed Description

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Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.

Conditions

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End Stage Renal Disease Kidney Transplantation Bone Loss Fractures Vascular Calcifications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3 plus Calcitriol

1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months

1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Vitamin D3 1000 IU per day for 12 months

Calcitriol

Intervention Type DRUG

Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months

Vitamin D3 plus Placebo

1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months

1 pill of placebo (sugar pill) per day for 12 months

Group Type PLACEBO_COMPARATOR

Vitamin D3

Intervention Type DRUG

Vitamin D3 1000 IU per day for 12 months

Placebo

Intervention Type DRUG

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

Interventions

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Vitamin D3

Vitamin D3 1000 IU per day for 12 months

Intervention Type DRUG

Calcitriol

Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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cholecalciferol Rocaltrol

Eligibility Criteria

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Inclusion Criteria

* Age older than 18
* Self-describes as White race

Exclusion Criteria

* Lower extremity amputations
* Non-ambulatory
* Paget´s disease of bone
* Current hyperthyroidism, untreated hypothyroidism
* Medical diseases (end stage liver, intestinal malabsorption)
* Use within the prior year pod anti-seizure medications that induce the cytochrome P450 system, testosterone, estrogen, selective estrogen receptor modulators
* Weight \>300 pounds
* Dual organ transplant
* Myocardial infarction or stroke
* Tobacco use within the past year

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No