Trial Outcomes & Findings for Effect of Vitamin D3 on Vascular Function (NCT NCT00948298)
NCT ID: NCT00948298
Last Updated: 2018-07-17
Results Overview
The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
12 Weeks
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
Placebo
Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3 will be given every 4 weeks.
|
Vitamin D
Two 50,000 IU tablets of oral Vitamin D3 given every 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
55
|
60
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Vitamin D3 on Vascular Function
Baseline characteristics by cohort
| Measure |
Placebo
n=65 Participants
Placebo: Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
|
Vitamin D
n=65 Participants
Vitamin D: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-39 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Customized
40-59 years
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Customized
60 years and above
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
25.0-29.9 kg/m^2
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
>30 kg/m^2
|
47 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Waist Circumference Groups
Low (<102 cm for male and <88 cm for female)
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Waist Circumference Groups
High (>=102 cm for male and >=88 cm for female)
|
48 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Blood Pressure (Systolic)
|
128.5 mmHg
STANDARD_DEVIATION 15.2 • n=5 Participants
|
125.2 mmHg
STANDARD_DEVIATION 16.1 • n=7 Participants
|
126.8 mmHg
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Blood Pressure (Diastolic)
|
84.5 mmHg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
80.9 mmHg
STANDARD_DEVIATION 11.4 • n=7 Participants
|
82.7 mmHg
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Augmentation Index
|
31.0 percentage of central pulse pressure
STANDARD_DEVIATION 12.0 • n=5 Participants
|
28.2 percentage of central pulse pressure
STANDARD_DEVIATION 11.2 • n=7 Participants
|
29.6 percentage of central pulse pressure
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Urine Isoprostane
|
14.9 ng/mg
STANDARD_DEVIATION 15.8 • n=5 Participants
|
14.4 ng/mg
STANDARD_DEVIATION 11.6 • n=7 Participants
|
14.6 ng/mg
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Serum 25(OH)D Level
|
16.5 nmol/L
STANDARD_DEVIATION 5.0 • n=5 Participants
|
17.0 nmol/L
STANDARD_DEVIATION 5.2 • n=7 Participants
|
16.8 nmol/L
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Serum Calcium Level
|
9.3 mg/dl
STANDARD_DEVIATION 0.4 • n=5 Participants
|
9.4 mg/dl
STANDARD_DEVIATION 0.3 • n=7 Participants
|
9.4 mg/dl
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Intact Parathyroid Hormone (PTH) Level
|
49.9 pmol/L
STANDARD_DEVIATION 33.6 • n=5 Participants
|
43.4 pmol/L
STANDARD_DEVIATION 19.9 • n=7 Participants
|
46.7 pmol/L
STANDARD_DEVIATION 27.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksThe primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo: Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
|
Vitamin D
n=65 Participants
Vitamin D: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
|
|---|---|---|
|
Pulse Wave Velocity for Vascular Stiffness
|
29.3 m/s
Standard Deviation 11.0
|
27.6 m/s
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 12 weeksImproved vascular function as determined by measuring sitting and 24 Hour Ambulatory Blood Pressure.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo: Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
|
Vitamin D
n=65 Participants
Vitamin D: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
|
|---|---|---|
|
Changes in Sitting and 24 Ambulatory Blood Pressure
Blood Pressure (Systolic)
|
125.8 mmHg
Standard Deviation 13.3
|
126.9 mmHg
Standard Deviation 15.0
|
|
Changes in Sitting and 24 Ambulatory Blood Pressure
Blood Pressure (Diastolic)
|
82.2 mmHg
Standard Deviation 9.2
|
81.1 mmHg
Standard Deviation 12.0
|
|
Changes in Sitting and 24 Ambulatory Blood Pressure
24 Hour Blood Pressure (Systolic)
|
128.4 mmHg
Standard Deviation 14.0
|
127.4 mmHg
Standard Deviation 16.4
|
|
Changes in Sitting and 24 Ambulatory Blood Pressure
24 Hour Blood Pressure (Diastolic)
|
83.9 mmHg
Standard Deviation 10.1
|
82.0 mmHg
Standard Deviation 11.6
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Vitamin D
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=65 participants at risk
Two tablets of oral placebo (microcrystalline cellulose), matching in appearance to the Vitamin D3, will be given every 4 weeks.
|
Vitamin D
n=65 participants at risk
Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Surgical and medical procedures
Post Biopsy Bleeding at Wound Site
|
1.5%
1/65 • Number of events 2 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumor
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 3 • 12 Weeks
|
|
Vascular disorders
Elevated Blood Pressure
|
1.5%
1/65 • Number of events 3 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Immune system disorders
Allergic Reaction
|
1.5%
1/65 • Number of events 4 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Cardiac disorders
Atypical Chest Pain
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 3 • 12 Weeks
|
|
General disorders
Syncope
|
1.5%
1/65 • Number of events 2 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
Other adverse events
| Measure |
Placebo
n=65 participants at risk
Two tablets of oral placebo (microcrystalline cellulose), matching in appearance to the Vitamin D3, will be given every 4 weeks.
|
Vitamin D
n=65 participants at risk
Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin = 9.6 G/DL
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Blood and lymphatic system disorders
High Platelet Count = 493 Thousand/UL
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Blood and lymphatic system disorders
Hematocrit = 30.2%
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Blood and lymphatic system disorders
Elevated WBC = 14.9
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Blood and lymphatic system disorders
Low White Blood Cell Count = 2.9
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Blood and lymphatic system disorders
Peripheral Edema, Left and Right Feet
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Blood and lymphatic system disorders
Low Platelet Count = 107
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Blood and lymphatic system disorders
Elevated Platelet = 456
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Endocrine disorders
Elevated iPTH = 213
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Endocrine disorders
Elevated iPTH = 236
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Gastrointestinal disorders
Elevated SGOT = 103
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Gastrointestinal disorders
Elevated SGPT = 106
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Hepatobiliary disorders
Gallbladder Removed
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Infections and infestations
Infection at Biopsy Site
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Metabolism and nutrition disorders
Phosphate = 5.0 MG/DL
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Metabolism and nutrition disorders
iPTH = 7 PG/ML
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 2 • 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Discomfort from Car Accident
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Right Hip Pain; Osteoarthritis Flare Up; Exacerbation
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumor
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Renal and urinary disorders
Creatinine = 1.44 MG/DL
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Renal and urinary disorders
Creatinine Random Urine = 461.3
|
0.00%
0/65 • 12 Weeks
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin Sensitivity to Adhesive Tape Post Biopsy
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
|
Vascular disorders
Elevated Blood Pressure
|
1.5%
1/65 • Number of events 1 • 12 Weeks
|
0.00%
0/65 • 12 Weeks
|
Additional Information
Dr. David Martins
Charles Drew University of Medicine and Science
Phone: 323-568-3353
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place