Trial Outcomes & Findings for Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents (NCT NCT01102374)
NCT ID: NCT01102374
Last Updated: 2017-04-21
Results Overview
ARIs defined as upper or lower respiratory infections
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
12 months
Results posted on
2017-04-21
Participant Flow
Participant milestones
| Measure |
High Dose Vitamin D
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
52
|
|
Overall Study
COMPLETED
|
39
|
33
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
High Dose Vitamin D
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Overall Study
Death
|
9
|
13
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
Baseline Characteristics
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Baseline characteristics by cohort
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80 years
STANDARD_DEVIATION 10 • n=5 Participants
|
82 years
STANDARD_DEVIATION 10 • n=7 Participants
|
81 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
52 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
25-hydroxyvitamin D level
|
23.0 ng/ml
STANDARD_DEVIATION 8.4 • n=5 Participants
|
23.0 ng/ml
STANDARD_DEVIATION 9.9 • n=7 Participants
|
23.0 ng/ml
STANDARD_DEVIATION 9.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsARIs defined as upper or lower respiratory infections
Outcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Number of Acute Respiratory Infections (ARIs)
|
32 events
|
48 events
|
SECONDARY outcome
Timeframe: 12 monthARIs resulting in emergency department visits or hospitalizations
Outcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Severity of Acute Respiratory Infections
|
3 events
|
6 events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Time to First ARI
|
0.59 Hazard Ratio
|
1.00 Hazard Ratio
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Change in 25-hydroxyvitamin D (25OHD) Level
|
8.18 ng/mL
Standard Error 0.75
|
2.71 ng/mL
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Issue relating to sample collection/processing precluded measurement of PTH level in the trial
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Falls
|
70 Events
|
27 Events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Fractures
|
5 events
|
8 events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Number of Upper Respiratory Infections
|
21 events
|
36 events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Number of Lower Respiratory Infections
|
11 events
|
12 events
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: collected together with lower respiratory infections (not as a separate category)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Incident Kidney Stones
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Incident Hypercalcemia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Death
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Number of Urinary Tract Infections
|
38 events
|
22 events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
High Dose Vitamin D
n=55 Participants
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 Participants
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Number of Other Infections
|
33 events
|
43 events
|
Adverse Events
High Dose Vitamin D
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
Standard Dose Vitamin D
Serious events: 13 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose Vitamin D
n=55 participants at risk
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 participants at risk
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
General disorders
Death
|
16.4%
9/55 • Number of events 9
|
25.0%
13/52 • Number of events 13
|
Other adverse events
| Measure |
High Dose Vitamin D
n=55 participants at risk
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D: Vitamin D3 100,000 IU monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
Standard Dose Vitamin D
n=52 participants at risk
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D: Vitamin D 12,000 IU monthly
Placebo: Placebo monthly
Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
12.7%
7/55
|
7.7%
4/52
|
|
Cardiac disorders
Cardiac disorders
|
27.3%
15/55
|
17.3%
9/52
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
10.9%
6/55
|
1.9%
1/52
|
|
Endocrine disorders
Endocrine disorders
|
5.5%
3/55
|
0.00%
0/52
|
|
Eye disorders
Eye disorders
|
9.1%
5/55
|
13.5%
7/52
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
40.0%
22/55
|
51.9%
27/52
|
|
General disorders
General disorders
|
70.9%
39/55
|
53.8%
28/52
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.8%
1/55
|
1.9%
1/52
|
|
Immune system disorders
Immune system disorders
|
16.4%
9/55
|
13.5%
7/52
|
|
Infections and infestations
Infections and infestations
|
38.2%
21/55
|
40.4%
21/52
|
|
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications
|
52.7%
29/55
|
57.7%
30/52
|
|
Investigations
Investigations
|
29.1%
16/55
|
23.1%
12/52
|
|
Metabolism and nutrition disorders
Metabolic and nutrition disorders
|
32.7%
18/55
|
28.8%
15/52
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
30.9%
17/55
|
30.8%
16/52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
1.8%
1/55
|
1.9%
1/52
|
|
Nervous system disorders
Nervous system disorders
|
18.2%
10/55
|
19.2%
10/52
|
|
Psychiatric disorders
Psychiatric disorders
|
54.5%
30/55
|
36.5%
19/52
|
|
Renal and urinary disorders
Renal and urinary disorders
|
23.6%
13/55
|
19.2%
10/52
|
|
Reproductive system and breast disorders
Reproductive system disorders
|
10.9%
6/55
|
3.8%
2/52
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
43.6%
24/55
|
57.7%
30/52
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders
|
41.8%
23/55
|
42.3%
22/52
|
|
Social circumstances
Social circumstances
|
1.8%
1/55
|
0.00%
0/52
|
|
Surgical and medical procedures
Surgical and medical procedures
|
25.5%
14/55
|
11.5%
6/52
|
Additional Information
Adit Ginde, MD, MPH, Professor of Emergency Medicine
University of Colorado School of Medicine
Phone: 720-848-6777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place