Safety of Vitamin D Supplementation in Older Persons

December 2, 2016 updated by: Silvina Levis, MD, University of Miami

Safety of Vitamin D Supplementation in the Elderly

This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.

Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 95 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ambulatory

Exclusion Criteria:

  • hypercalcemia
  • hypercalciuria > 4 mg/kg body weight/day
  • primary, secondary, or tertiary hyperparathyroidism
  • renal insufficiency (serum creatinine > 2 mg/dL )
  • history of nephrolithiasis
  • treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol)
  • treatment with anticonvulsants
  • Paget's disease
  • severe cardiac, pulmonary, hepatic, renal, or neurological disease
  • life expectancy < 1 year
  • participation in another trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
vitamin D (cholecalciferol) 400 IU daily orally - low dose
Dietary supplement: cholecalciferol (vitamin D)
400 IU daily (low dose)
Dietary supplement: cholecalciferol (vitamin D)
2000 IU daily (high dose)
Active Comparator: 2
vitamin D (cholecalciferol) 2000 IU daily orally - high dose
Dietary supplement: cholecalciferol (vitamin D)
400 IU daily (low dose)
Dietary supplement: cholecalciferol (vitamin D)
2000 IU daily (high dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Develop Hypercalcemia
Time Frame: 6 months
calcium serum levels measured at baseline and at the end of the intervention (6-months)
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Serum 25-hydroxyvitamin D Levels
Time Frame: baseline and 6 months
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Silvina Levis, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20070018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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