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Trial Outcomes & Findings for Vitamin D in Vulnerable Adults (VIVA-VA) (NCT NCT01170273)

NCT ID: NCT01170273

Last Updated: 2016-12-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

130 participants

Primary outcome timeframe

baseline and 9 months

Results posted on

2016-12-21

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo Arm
placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months
Cholecalciferol 4000 IU
cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months
Overall Study
STARTED
64
66
Overall Study
COMPLETED
56
57
Overall Study
NOT COMPLETED
8
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo Arm
placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months
Cholecalciferol 4000 IU
cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months
Overall Study
Lost to Follow-up
6
8
Overall Study
Protocol Violation
1
0
Overall Study
Death
1
0
Overall Study
Adverse Event
0
1

Baseline Characteristics

Vitamin D in Vulnerable Adults (VIVA-VA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo Arm
n=64 Participants
placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months
Cholecalciferol 4000 IU
n=66 Participants
cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months
Total
n=130 Participants
Total of all reporting groups
Age, Continuous
73.0 years
STANDARD_DEVIATION 7.3 • n=5 Participants
71.8 years
STANDARD_DEVIATION 6.3 • n=7 Participants
72.4 years
STANDARD_DEVIATION 6.8 • n=5 Participants
Gender
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Gender
Male
64 Participants
n=5 Participants
66 Participants
n=7 Participants
130 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo Arm
n=56 Participants
placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months
Cholecalciferol 4000 IU
n=57 Participants
cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months
Change in Short Physical Performance Battery Test Score
7.3 units on a scale
Standard Deviation 1.69
7.0 units on a scale
Standard Deviation 1.62

Adverse Events

Placebo Arm

Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths

Cholecalciferol 4000 IU

Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo Arm
n=64 participants at risk
placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months
Cholecalciferol 4000 IU
n=66 participants at risk
cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months
Skin and subcutaneous tissue disorders
cancer
1.6%
1/64 • Number of events 1
0.00%
0/66
Respiratory, thoracic and mediastinal disorders
pneumonia
1.6%
1/64 • Number of events 1
0.00%
0/66
Renal and urinary disorders
renal mass
0.00%
0/64
1.5%
1/66 • Number of events 1
Cardiac disorders
pulmonary edema
1.6%
1/64 • Number of events 1
0.00%
0/66
Renal and urinary disorders
renal failure
0.00%
0/64
1.5%
1/66 • Number of events 1
Renal and urinary disorders
prostate cancer
1.6%
1/64 • Number of events 1
0.00%
0/66
Respiratory, thoracic and mediastinal disorders
lung cancer
1.6%
1/64 • Number of events 1
0.00%
0/66

Other adverse events

Other adverse events
Measure
Placebo Arm
n=64 participants at risk
placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months
Cholecalciferol 4000 IU
n=66 participants at risk
cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months
Endocrine disorders
hypercalcemia
1.6%
1/64
4.5%
3/66
Injury, poisoning and procedural complications
fall
17.2%
11/64
12.1%
8/66

Additional Information

Silvina Levis MD

Miami VA Medical Center

Phone: 305-575-3388

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place