Trial Outcomes & Findings for Vitamin D and Vascular Health in Children (NCT NCT01797302)
NCT ID: NCT01797302
Last Updated: 2020-06-24
Results Overview
Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
6 months
Results posted on
2020-06-24
Participant Flow
Participant milestones
| Measure |
Vitamin D3 2000 IU
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
76
|
|
Overall Study
3 Month Visit
|
60
|
57
|
57
|
|
Overall Study
COMPLETED
|
58
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
17
|
26
|
26
|
Reasons for withdrawal
| Measure |
Vitamin D3 2000 IU
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
23
|
22
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
4
|
Baseline Characteristics
Vitamin D and Vascular Health in Children
Baseline characteristics by cohort
| Measure |
Vitamin D3 2000 IU
n=75 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=74 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=76 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.9 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
13.5 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
13.5 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
13.6 years
STANDARD_DEVIATION 2.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hawaiian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Body Mass Index
|
30.3 "kg/m^2"
STANDARD_DEVIATION 5.8 • n=5 Participants
|
30.0 "kg/m^2"
STANDARD_DEVIATION 6.1 • n=7 Participants
|
30.7 "kg/m^2"
STANDARD_DEVIATION 6.9 • n=5 Participants
|
30.3 "kg/m^2"
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
Obese (BMI > or = 95th percentile)
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Serum 25-hydroxyvitamin D (25[OH]D)
|
14.2 ng/mL
STANDARD_DEVIATION 3.5 • n=5 Participants
|
14.4 ng/mL
STANDARD_DEVIATION 3.4 • n=7 Participants
|
14.3 ng/mL
STANDARD_DEVIATION 4.3 • n=5 Participants
|
14.3 ng/mL
STANDARD_DEVIATION 3.7 • n=4 Participants
|
|
Serum parathyroid hormone (PTH)
|
52.0 pg/mL
STANDARD_DEVIATION 19.9 • n=5 Participants
|
45.7 pg/mL
STANDARD_DEVIATION 18.0 • n=7 Participants
|
51.7 pg/mL
STANDARD_DEVIATION 20.6 • n=5 Participants
|
49.8 pg/mL
STANDARD_DEVIATION 19.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intention to treat with all available data
Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=58 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=47 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=50 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Flow-mediated Dilation (FMD) Percentage
|
7.61 percentage of baseline dilation
Standard Deviation 5.15
|
8.27 percentage of baseline dilation
Standard Deviation 5.92
|
7.31 percentage of baseline dilation
Standard Deviation 5.14
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to tread with all available data
PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness.
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=52 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=43 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=45 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Pulse-wave Velocity (PWV)
|
4.85 meters/second
Standard Deviation 0.76
|
4.85 meters/second
Standard Deviation 0.63
|
4.88 meters/second
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
AIx-75 is a measure of arterial stiffness. AIx was measured through radial arterial tonometry using SphygmoCor. Radial pulse waveform are analyzed through an automatic software function to determine aortic pulse waveform and aortic or central systolic (cSBP) and diastolic blood pressure (cDBP), and these measurements are further analyzed automatically to calculate AIx. AIx is a composite measure of the magnitude of wave reflection and arterial stiffness in all conduit arteries which affect the timing of the wave reflection. AIx = P2-P1/cSBP-cDBP, where P1 is the height of the incident pressure wave form during systole, P2 is the height of the reflected wave added to the incident wave, cSBP is the aortic systolic BP, and cDBP is the aortic diastolic BP. AIx adjusted to heart rate of 75 beats/min (AIx-75) is a validated index of arterial stiffness, with higher values indicating higher degree of arterial stiffness.
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=57 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=46 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=44 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)
|
3.75 ratio
Standard Deviation 8.44
|
2.22 ratio
Standard Deviation 10.97
|
1.74 ratio
Standard Deviation 10.29
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
a measure of cardiometabolic health
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=57 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=46 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=44 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Central Systolic Blood Pressure
|
98.45 mmHg
Standard Deviation 7.20
|
96.05 mmHg
Standard Deviation 8.19
|
98.50 mmHg
Standard Deviation 7.84
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
a measure of cardiometabolic health
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=57 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=46 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=44 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Central Diastolic Blood Pressure
|
68.69 mmHg
Standard Deviation 5.87
|
65.33 mmHg
Standard Deviation 8.27
|
68.57 mmHg
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
a measure of cardiometabolic health
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=58 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=48 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=50 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Systemic Systolic Blood Pressure
|
114.71 mmHg
Standard Deviation 8.45
|
114.88 mmHg
Standard Deviation 11.76
|
115.70 mmHg
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
a measure of cardiometabolic health
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=58 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=48 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=50 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Systemic Diastolic Blood Pressure
|
67.57 mmHg
Standard Deviation 5.81
|
64.73 mmHg
Standard Deviation 8.44
|
67.30 mmHg
Standard Deviation 6.53
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
a measure of cardiometabolic health
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=58 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=48 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=50 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Fasting Blood Glucose
|
88.41 mg/dL
Standard Deviation 6.33
|
88.48 mg/dL
Standard Deviation 7.05
|
90.44 mg/dL
Standard Deviation 6.04
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
1/fasting insulin ratio is a measure of insulin sensitivity. Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity.
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=56 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=44 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=47 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
1/Fasting Insulin Ratio
|
0.08 ratio
Standard Deviation 0.06
|
0.06 ratio
Standard Deviation 0.04
|
0.06 ratio
Standard Deviation 0.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: intention to treat with all available data
a surrogate measure of adiposity
Outcome measures
| Measure |
Vitamin D3 2000 IU
n=58 Participants
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=48 Participants
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=50 Participants
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Body Mass Index (BMI)
|
30.82 "kg/m^2"
Standard Deviation 6.12
|
30.99 "kg/m^2"
Standard Deviation 6.41
|
30.62 "kg/m^2"
Standard Deviation 6.78
|
Adverse Events
Vitamin D3 2000 IU
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Vitamin D3 1000 IU
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Vitamin D3 600 IU
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin D3 2000 IU
n=75 participants at risk
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=74 participants at risk
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=76 participants at risk
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
Other adverse events
| Measure |
Vitamin D3 2000 IU
n=75 participants at risk
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 1000 IU
n=74 participants at risk
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
Vitamin D3 600 IU
n=76 participants at risk
Vitamin D3 600 IU tablet by mouth once daily for 6 months
Vitamin D3: Tablet form
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
12.0%
9/75 • Number of events 9 • 6 months
|
10.8%
8/74 • Number of events 8 • 6 months
|
10.5%
8/76 • Number of events 8 • 6 months
|
|
Nervous system disorders
Headache
|
4.0%
3/75 • Number of events 3 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.3%
1/75 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
1/75 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
Flu like symptoms
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/75 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/75 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning, and proc complications other
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Infections and infestations
Sinusitis
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/75 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
|
Immune system disorders
Allergic reaction
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
Fever
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders other
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures other
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
|
Nervous system disorders
Syncope
|
1.3%
1/75 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
0.00%
0/76 • 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/75 • 6 months
|
0.00%
0/74 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/75 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
Additional Information
Kumaravel Rajakumar
University of Pittsburgh School of Medicine
Phone: 412-692-5822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place