Trial Outcomes & Findings for Vitamin D Repletion in Coronary Artery Disease (NCT NCT01570309)
NCT ID: NCT01570309
Last Updated: 2013-10-10
Results Overview
Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
COMPLETED
NA
96 participants
Baseline and 12 weeks
2013-10-10
Participant Flow
Recruitment from October 2008 through December 2010 from the cardiac catheterization laboratories and outpatient clinics of the Jacobi Medical Center and Montefiore Medical Center in the Northeastern section of the Bronx, NY. Additional recruitment occurred at Crystal Run Health in Orange County, NY.
Subjects with ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization, were screened for vitamin D deficiency by measurement of serum 25-hydroxyvitamin D (25-vitamin D).Eligible subjects with a 25-vitamin D level \< 20 ng/ml were randomly assigned 1:1 to active or placebo treatment
Participant milestones
| Measure |
Ergocalciferol
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Ergocalciferol
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
Matching placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Vitamin D Repletion in Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Ergocalciferol
n=48 Participants
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=48 Participants
Matching placebo
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age Continuous
|
54.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
48 participants
n=7 Participants
|
96 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Assuming a standard deviation of 0.6 in the change in RH-PAT score from baseline to 12 weeks, we estimated that the study would need a sample size of 45 patients per treatment group to have 80% power at a two tailed alpha=0.05 level to detect a minimum difference in change in RH-PAT score of 0.36 between treatment groups.
Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
Outcome measures
| Measure |
Ergocalciferol
n=45 Participants
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=45 Participants
Matching placebo
|
|---|---|---|
|
Endothelial Function
|
0.13 reactive hypermia index
Interval -0.235 to 0.495
|
-0.04 reactive hypermia index
Interval -0.355 to 0.275
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksMedian within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups
Outcome measures
| Measure |
Ergocalciferol
n=45 Participants
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=45 Participants
Matching placebo
|
|---|---|---|
|
Inflammation -
|
-0.17 mg/dl
Interval -1.82 to 1.48
|
-0.05 mg/dl
Interval -0.96 to 0.86
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksMedian within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups
Outcome measures
| Measure |
Ergocalciferol
n=45 Participants
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=45 Participants
Matching placebo
|
|---|---|---|
|
Inflammation
|
-2.29 pg/ml
Interval -13.34 to 8.76
|
-2.8 pg/ml
Interval -8.78 to 3.18
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksMedian within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups
Outcome measures
| Measure |
Ergocalciferol
n=45 Participants
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=45 Participants
Matching placebo
|
|---|---|---|
|
Inflammation
|
-7.45 pg/ml
Interval -27.35 to 12.45
|
-2.72 pg/ml
Interval -15.12 to 9.68
|
PRIMARY outcome
Timeframe: Baseline to week 12Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups
Outcome measures
| Measure |
Ergocalciferol
n=45 Participants
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=45 Participants
Matching placebo
|
|---|---|---|
|
Inflammation
|
-10.96 pg/ml
Interval -43.46 to 21.54
|
-2.33 pg/ml
Interval -27.18 to 22.52
|
Adverse Events
Ergocalciferol
Sugar Pill
Serious adverse events
| Measure |
Ergocalciferol
n=45 participants at risk
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=45 participants at risk
Matching placebo
|
|---|---|---|
|
Cardiac disorders
Death
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Heart failure exacerbation
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Syncope
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Injury, poisoning and procedural complications
Trauma
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
ICD shock inappropriate
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Angina
|
0.00%
0/45
|
6.7%
3/45 • Number of events 3
|
|
Metabolism and nutrition disorders
Gout
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Cardiac disorders
Atypical chest pain
|
2.2%
1/45 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
Other adverse events
| Measure |
Ergocalciferol
n=45 participants at risk
50,000 units of ergocalciferol once a week for 12 weeks
|
Sugar Pill
n=45 participants at risk
Matching placebo
|
|---|---|---|
|
General disorders
Headache
|
8.9%
4/45
|
8.9%
4/45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place