Phase 3
N=105
Safety of Vitamin D Supplementation in Older Persons
Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00681590 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Participants Who Develop Hypercalcemia — 0; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- cholecalciferol (vitamin D) (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Develop Hypercalcemia |
0; 2 | — |
| SECONDARY Change From Baseline in Serum 25-hydroxyvitamin D Levels |
-0.5; 6.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00681590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.