Phase 3
Completed N=105
Safety of Vitamin D Supplementation in Older Persons
Source: ClinicalTrials.gov NCT00681590 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants Who Develop Hypercalcemia — 0; 2 participants
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.
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 | — |
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. Informational only — not medical advice.