Frail Elderly, Vitamin d Deficiency
Conditions
Keywords
aged, vitamin d deficiency
Brief summary
Vitamin D insufficiency is a problem of growing concern, given its prevalence in older persons and the association of low vitamin D with multiple major health problems, including mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain cancers. Sedentary persons are particularly vulnerable for these health problems and generally not adherent to prescribed physical activity. This study will investigate if treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.
Interventions
DIETARY_SUPPLEMENTvitamin D
cholecalciferol
DIETARY_SUPPLEMENTplacebo
placebo tablet
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
65 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* male veterans * 65 to 95 years of age * independent * sedentary * vitamin D insufficiency
Exclusion criteria
* hypercalcemia * renal failure * living in a nursing home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Physical Performance Battery Test Score | baseline and 9 months | The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Arm placebo capsule
placebo: placebo tablet
participants received one daily tablet containing placebo for 9 months | 64 |
| Cholecalciferol 4000 IU cholecalciferol 4000 IU daily
vitamin D: cholecalciferol
participants received one daily tablet containing cholecalciferol 4000 IU for 9 months | 66 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo Arm | Cholecalciferol 4000 IU | Total |
|---|---|---|---|
| Age, Continuous | 73.0 years STANDARD_DEVIATION 7.3 | 71.8 years STANDARD_DEVIATION 6.3 | 72.4 years STANDARD_DEVIATION 6.8 |
| Gender Female | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 64 Participants | 66 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 64 | 11 / 66 |
| serious Total, serious adverse events | 5 / 64 | 2 / 66 |
Outcome results
Primary
Change in Short Physical Performance Battery Test Score
The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.
Time frame: baseline and 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Arm | Change in Short Physical Performance Battery Test Score | 7.3 units on a scale | Standard Deviation 1.69 |
| Cholecalciferol 4000 IU | Change in Short Physical Performance Battery Test Score | 7.0 units on a scale | Standard Deviation 1.62 |