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Safety of Vitamin D Supplementation in Older Persons

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol (vitamin D)
cholecalciferol (vitamin D)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring vitamin D, deficiency, elderly

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

vitamin D (cholecalciferol) 400 IU daily orally - low dose

vitamin D (cholecalciferol) 2000 IU daily orally - high dose

Outcomes

Primary Outcome Measures

Number of Participants Who Develop Hypercalcemia
calcium serum levels measured at baseline and at the end of the intervention (6-months)

Secondary Outcome Measures

Change From Baseline in Serum 25-hydroxyvitamin D Levels

Full Information

First Posted
May 15, 2008
Last Updated
December 2, 2016
Sponsor
University of Miami
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00681590
Brief Title
Safety of Vitamin D Supplementation in Older Persons
Official Title
Safety of Vitamin D Supplementation in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D, deficiency, elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
vitamin D (cholecalciferol) 400 IU daily orally - low dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
vitamin D (cholecalciferol) 2000 IU daily orally - high dose
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol (vitamin D)
Intervention Description
400 IU daily (low dose)
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol (vitamin D)
Intervention Description
2000 IU daily (high dose)
Primary Outcome Measure Information:
Title
Number of Participants Who Develop Hypercalcemia
Description
calcium serum levels measured at baseline and at the end of the intervention (6-months)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum 25-hydroxyvitamin D Levels
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvina Levis, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23553992
Citation
Lagari V, Gomez-Marin O, Levis S. The role of vitamin D in improving physical performance in the elderly. J Bone Miner Res. 2013 Oct;28(10):2194-201. doi: 10.1002/jbmr.1949.
Results Reference
background
PubMed Identifier
22784845
Citation
Lagari VS, Gomez-Marin O, Levis S. Differences in vitamin D3 dosing regimens in a geriatric community-dwelling population. Endocr Pract. 2012 Nov-Dec;18(6):847-54. doi: 10.4158/EP12081.OR.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23553992
Description
link to Pubmed abstract

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Safety of Vitamin D Supplementation in Older Persons

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