Safety of Vitamin D Supplementation in Older Persons
1 other identifier
interventional
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
March 7, 2016
CompletedJanuary 26, 2017
December 1, 2016
1 year
May 15, 2008
February 5, 2016
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Develop Hypercalcemia
calcium serum levels measured at baseline and at the end of the intervention (6-months)
6 months
Secondary Outcomes (1)
Change From Baseline in Serum 25-hydroxyvitamin D Levels
baseline and 6 months
Study Arms (2)
1
ACTIVE COMPARATORvitamin D (cholecalciferol) 400 IU daily orally - low dose
2
ACTIVE COMPARATORvitamin D (cholecalciferol) 2000 IU daily orally - high dose
Interventions
Eligibility Criteria
You may qualify if:
- ambulatory
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
Related Publications (2)
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.
PMID: 23553992BACKGROUNDLagari 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.
PMID: 22784845RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Silvina Levis
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Silvina Levis, MD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 21, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
January 26, 2017
Results First Posted
March 7, 2016
Record last verified: 2016-12