Trial Outcomes & Findings for Vitamin D, Insulin Resistance, and Cardiovascular Disease (NCT NCT00736632)
NCT ID: NCT00736632
Last Updated: 2020-02-10
Results Overview
24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
0, 2, and 4 months
Results posted on
2020-02-10
Participant Flow
Potential participants will contact the principal investigator or research team through recruitment materials including emails to Washington University/Barnes Jewish/Children's staff, flyers, referrals through other physicians or the recruitment enhancement core, the Veterans Affairs Medical Center and Grace Hill Family Medical Center.
The third arm signed consent and are enrolled in the study but only for a single blood draw. They were not randomized and did not receive any intervention. No data was collected for any pre-specified primary or secondary outcomes from these participants.
Participant milestones
| Measure |
Placebo
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
Non-Intervention Blood Collection
Subjects without intervention will give a one-time blood sample for analysis of monocytes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
50
|
31
|
|
Overall Study
COMPLETED
|
44
|
50
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
Non-intervention Blood Collection
n=31 Participants
Patients received no intervention. This is a one-time blood collection only.
|
Total
n=125 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
50 participants
n=7 Participants
|
31 participants
n=5 Participants
|
125 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0, 2, and 4 monthsPopulation: Occasional patients had missing blood pressure data or dropped out of the study prior to completion.
24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
0 Month, Daytime MAP
|
99.8 mm Hg
Standard Deviation 6.3
|
101.6 mm Hg
Standard Deviation 7.6
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
0 Month, Office SBP
|
126.6 mm Hg
Standard Deviation 14.3
|
131.1 mm Hg
Standard Deviation 14.9
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
0 Month, Office DBP
|
79.2 mm Hg
Standard Deviation 10.7
|
78.9 mm Hg
Standard Deviation 10.4
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
2 Month, Office SBP
|
127.6 mm Hg
Standard Deviation 16.4
|
133.2 mm Hg
Standard Deviation 14.7
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
2 Month, Office DBP
|
79.2 mm Hg
Standard Deviation 10.5
|
79.9 mm Hg
Standard Deviation 11.2
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
4 Month, Office SBP
|
129.6 mm Hg
Standard Deviation 16.9
|
132.7 mm Hg
Standard Deviation 13.0
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
4 Month, Office DBP
|
79.6 mm Hg
Standard Deviation 9.5
|
77.9 mm Hg
Standard Deviation 12.0
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
0 Month, Central MAP
|
103.9 mm Hg
Standard Deviation 9.3
|
107.2 mm Hg
Standard Deviation 9.9
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
2 Month, Central MAP
|
100.6 mm Hg
Standard Deviation 9.0
|
107.8 mm Hg
Standard Deviation 12.0
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
4 Month, Central MAP
|
102.6 mm Hg
Standard Deviation 9.3
|
105.2 mm Hg
Standard Deviation 12.8
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
0 Month, Nighttime MAP
|
89.4 mm Hg
Standard Deviation 8.2
|
92.2 mm Hg
Standard Deviation 9.8
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
2 Month, Daytime MAP
|
97.6 mm Hg
Standard Deviation 10.7
|
101.7 mm Hg
Standard Deviation 9.8
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
2 Month, Nighttime MAP
|
86.6 mm Hg
Standard Deviation 9.7
|
94.0 mm Hg
Standard Deviation 13.7
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
4 Month, Daytime MAP
|
100.0 mm Hg
Standard Deviation 10.7
|
99.1 mm Hg
Standard Deviation 9.7
|
|
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
4 Month, Nighttime MAP
|
89.1 mm Hg
Standard Deviation 12.0
|
90.3 mm Hg
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 0, 2, and 4 monthsPopulation: Some patients were unable to obtain adequate ultrasound images for BART analysis or did not show up for some visits
Brachial artery response to hyperemia assessed by measuring brachial artery diameter every 30 seconds for 180 seconds after a 5-minute occlusion with arm cuff above systolic blood pressure, with response defined as maximal percentage increase above baseline.
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
Brachial Artery Reactivity Testing
0 Month
|
7.8 percentage of dilation
Standard Deviation 5.9
|
8.6 percentage of dilation
Standard Deviation 5.6
|
|
Brachial Artery Reactivity Testing
2 Month
|
8.5 percentage of dilation
Standard Deviation 6.6
|
7.5 percentage of dilation
Standard Deviation 4.9
|
|
Brachial Artery Reactivity Testing
4 Month
|
7.8 percentage of dilation
Standard Deviation 4.6
|
7.8 percentage of dilation
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 0 and 4 monthsPopulation: This analysis was only performed in a subset of patients.
Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.
Outcome measures
| Measure |
Placebo
n=15 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=11 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
Macrophage Cholesterol Metabolism
|
1.01 unitless (ratio)
Standard Deviation 0.24
|
0.47 unitless (ratio)
Standard Deviation 0.072
|
SECONDARY outcome
Timeframe: 0, 2, and 4 MonthPopulation: 1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.
Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
Serum Calcium
0 Month, serum ca
|
9.1 mg/dL
Standard Deviation 0.5
|
9.1 mg/dL
Standard Deviation 0.4
|
|
Serum Calcium
2 Month, serum ca
|
9.2 mg/dL
Standard Deviation 0.4
|
9.1 mg/dL
Standard Deviation 0.4
|
|
Serum Calcium
4 Month, serum ca
|
9.1 mg/dL
Standard Deviation 0.4
|
9.3 mg/dL
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 0, 2, and 4 monthPopulation: 1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.
HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
HbA1C
HbA1c 0 month
|
7.0 percentage
Standard Deviation 1.2
|
7.0 percentage
Standard Deviation 1.2
|
|
HbA1C
HbA1c 2 month
|
7.4 percentage
Standard Deviation 1.8
|
6.9 percentage
Standard Deviation 1.2
|
|
HbA1C
HbA1c 4 month
|
7.4 percentage
Standard Deviation 1.9
|
7.0 percentage
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 0, 2, and 4 Month25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
Vitamin D
0 Month, Vitamin D
|
46.1 pg/mL
Standard Deviation 15.9
|
40.1 pg/mL
Standard Deviation 11.9
|
|
Vitamin D
2 Month, Vitamin D
|
37.7 pg/mL
Standard Deviation 16.0
|
40.7 pg/mL
Standard Deviation 11.3
|
|
Vitamin D
4 Month, Vitamin D
|
44.5 pg/mL
Standard Deviation 18.2
|
42.7 pg/mL
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: 0, 2, and 4 MonthPopulation: Several subjects were unable to give a sample at various time points.
High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
hsCRP
0 Month, hsCRP
|
3.7 mg/L
Standard Deviation 3.0
|
6.0 mg/L
Standard Deviation 7.0
|
|
hsCRP
2 Month, hsCRP
|
3.6 mg/L
Standard Deviation 2.9
|
5.9 mg/L
Standard Deviation 6.6
|
|
hsCRP
4 Month, hsCRP
|
4.2 mg/L
Standard Deviation 4.0
|
6.7 mg/L
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 0, 2, and 4 MonthPopulation: 1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.
Serum fasting glucose assessed by hexokinase method
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
Fasting Glucose
2 Month, Fasting Glucose
|
137.4 mg/dL
Standard Deviation 57.6
|
124.9 mg/dL
Standard Deviation 51.0
|
|
Fasting Glucose
0 Month, Fasting Glucose
|
126.7 mg/dL
Standard Deviation 34.5
|
123.3 mg/dL
Standard Deviation 39.1
|
|
Fasting Glucose
4 Month, Fasting Glucose
|
138.4 mg/dL
Standard Deviation 55.2
|
128.7 mg/dL
Standard Deviation 42.4
|
SECONDARY outcome
Timeframe: 0, 2 and 4 MonthsPopulation: 1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.
Urine calcium to creatinine ratio assessed by spectrophotometry
Outcome measures
| Measure |
Placebo
n=44 Participants
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily
|
Vitamin D
n=50 Participants
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
|
|---|---|---|
|
Urine Calcium to Creatinine Ratio.
0 Month, ca to creatinine ratio
|
69.8 mg/gm
Standard Deviation 49.8
|
88.1 mg/gm
Standard Deviation 94.8
|
|
Urine Calcium to Creatinine Ratio.
2 Month, ca to creatinine ratio
|
102.3 mg/gm
Standard Deviation 80.1
|
114.1 mg/gm
Standard Deviation 62.5
|
|
Urine Calcium to Creatinine Ratio.
4 Month, ca to creatinine ratio
|
89.9 mg/gm
Standard Deviation 80.9
|
134.5 mg/gm
Standard Deviation 106.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carlos Bernal-Mizrachi
Washington University in St. Louis
Phone: 314-362-0947
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place