Vitamin D Deficiency
Conditions
Keywords
vitamin D, deficiency, elderly
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.
Interventions
DIETARY_SUPPLEMENTcholecalciferol (vitamin D)
400 IU daily (low dose)
Sponsors
Merck Sharp & Dohme LLC
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Develop Hypercalcemia | 6 months | calcium serum levels measured at baseline and at the end of the intervention (6-months) |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Serum 25-hydroxyvitamin D Levels | baseline and 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D 400 IU participants received one tablet containing cholecalciferol 400 IU daily orally (low dose) | 34 |
| Vitamin D 2000 IU participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose) | 71 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 12 |
Baseline characteristics
| Characteristic | Vitamin D 400 IU | Vitamin D 2000 IU | Total |
|---|---|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 5.9 | 73.9 years STANDARD_DEVIATION 6.7 | 73.5 years STANDARD_DEVIATION 6.5 |
| Gender Female | 28 Participants | 59 Participants | 87 Participants |
| Gender Male | 6 Participants | 12 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 2 / 71 |
| serious Total, serious adverse events | 0 / 34 | 0 / 71 |
Outcome results
Primary
Number of Participants Who Develop Hypercalcemia
calcium serum levels measured at baseline and at the end of the intervention (6-months)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamin D 400 IU | Number of Participants Who Develop Hypercalcemia | 0 participants |
| Vitamin D 2000 IU | Number of Participants Who Develop Hypercalcemia | 2 participants |
Secondary
Change From Baseline in Serum 25-hydroxyvitamin D Levels
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D 400 IU | Change From Baseline in Serum 25-hydroxyvitamin D Levels | -0.5 ng/ml | Standard Deviation 1 |
| Vitamin D 2000 IU | Change From Baseline in Serum 25-hydroxyvitamin D Levels | 6.5 ng/ml | Standard Deviation 6 |