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Trial record 46 of 123 for:    hypertension "vitamin d"

Effect of Vitamin D3 on Vascular Function

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ClinicalTrials.gov Identifier: NCT00948298
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
David Martins, Charles Drew University of Medicine and Science

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Vitamin D Deficiency
Interventions Drug: Vitamin D
Drug: Placebo
Enrollment 130
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3 will be given every 4 weeks. Two 50,000 IU tablets of oral Vitamin D3 given every 4 weeks.
Period Title: Overall Study
Started 65 65
Completed 55 60
Not Completed 10 5
Arm/Group Title Placebo Vitamin D Total
Hide Arm/Group Description 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 will be given every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 65 65 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
18-39 years
10
  15.4%
10
  15.4%
20
  15.4%
40-59 years
47
  72.3%
45
  69.2%
92
  70.8%
60 years and above
8
  12.3%
10
  15.4%
18
  13.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Female
27
  41.5%
24
  36.9%
51
  39.2%
Male
38
  58.5%
41
  63.1%
79
  60.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 65 participants 65 participants 130 participants
65
 100.0%
65
 100.0%
130
 100.0%
Body Mass Index, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
25.0-29.9 kg/m^2
18
  27.7%
12
  18.5%
30
  23.1%
>30 kg/m^2
47
  72.3%
53
  81.5%
100
  76.9%
Waist Circumference Groups  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Low (<102 cm for male and <88 cm for female)
17
  26.2%
12
  18.5%
29
  22.3%
High (>=102 cm for male and >=88 cm for female)
48
  73.8%
53
  81.5%
101
  77.7%
Blood Pressure (Systolic)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 65 participants 65 participants 130 participants
128.5  (15.2) 125.2  (16.1) 126.8  (15.7)
Blood Pressure (Diastolic)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 65 participants 65 participants 130 participants
84.5  (10.5) 80.9  (11.4) 82.7  (11.1)
Augmentation Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of central pulse pressure
Number Analyzed 65 participants 65 participants 130 participants
31.0  (12.0) 28.2  (11.2) 29.6  (11.6)
[1]
Measure Description: Augmentation Index (Aix) is the percentage of central pulse pressure (central systolic minus diastolic pressure) attributable to the reflection of the pulse wave at arterial bifurcation points and interface of the large arteries and small resistance arteries. It is the index of aortic pressure wave reflection, defined as the ratio of augmented ascending aortic pressure (generated backward traveling pressure waves) to the central pulse pressure at the aortic root: where (Ps - Pi) / (Ps - Pd) Ps = peak systolic pressure, Pi = pressure at reflection point, and Pd = minimum diastolic pressure.
Urine Isoprostane  
Mean (Standard Deviation)
Unit of measure:  Ng/mg
Number Analyzed 65 participants 65 participants 130 participants
14.9  (15.8) 14.4  (11.6) 14.6  (13.8)
Serum 25(OH)D Level  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 65 participants 65 participants 130 participants
16.5  (5.0) 17.0  (5.2) 16.8  (5.1)
Serum Calcium Level  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 65 participants 65 participants 130 participants
9.3  (0.4) 9.4  (0.3) 9.4  (0.4)
Intact Parathyroid Hormone (PTH) Level  
Mean (Standard Deviation)
Unit of measure:  pmol/L
Number Analyzed 65 participants 65 participants 130 participants
49.9  (33.6) 43.4  (19.9) 46.7  (27.7)
1.Primary Outcome
Title Pulse Wave Velocity for Vascular Stiffness
Hide Description 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description:
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 will be given every 4 weeks.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: m/s
29.3  (11.0) 27.6  (11.0)
2.Secondary Outcome
Title Changes in Sitting and 24 Ambulatory Blood Pressure
Hide Description Improved vascular function as determined by measuring sitting and 24 Hour Ambulatory Blood Pressure.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description:
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 will be given every 4 weeks.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: mmHg
Blood Pressure (Systolic) 125.8  (13.3) 126.9  (15.0)
Blood Pressure (Diastolic) 82.2  (9.2) 81.1  (12.0)
24 Hour Blood Pressure (Systolic) 128.4  (14.0) 127.4  (16.4)
24 Hour Blood Pressure (Diastolic) 83.9  (10.1) 82.0  (11.6)
Time Frame 12 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description Two tablets of oral placebo (microcrystalline cellulose), matching in appearance to the Vitamin D3, will be given every 4 weeks. Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
All-Cause Mortality
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)      0/65 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/65 (6.15%)      4/65 (6.15%)    
Cardiac disorders     
Atypical Chest Pain   0/65 (0.00%)  0 1/65 (1.54%)  3
General disorders     
Syncope   1/65 (1.54%)  2 0/65 (0.00%)  0
Immune system disorders     
Allergic Reaction   1/65 (1.54%)  4 0/65 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycemia   0/65 (0.00%)  0 1/65 (1.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pituitary Tumor   0/65 (0.00%)  0 1/65 (1.54%)  3
Surgical and medical procedures     
Post Biopsy Bleeding at Wound Site   1/65 (1.54%)  2 0/65 (0.00%)  0
Vascular disorders     
Elevated Blood Pressure   1/65 (1.54%)  3 1/65 (1.54%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/65 (18.46%)      14/65 (21.54%)    
Blood and lymphatic system disorders     
Hemoglobin = 9.6 G/DL   0/65 (0.00%)  0 1/65 (1.54%)  1
High Platelet Count = 493 Thousand/UL   1/65 (1.54%)  1 0/65 (0.00%)  0
Hematocrit = 30.2%   0/65 (0.00%)  0 1/65 (1.54%)  1
Elevated WBC = 14.9   0/65 (0.00%)  0 1/65 (1.54%)  1
Low White Blood Cell Count = 2.9   0/65 (0.00%)  0 1/65 (1.54%)  1
Peripheral Edema, Left and Right Feet   1/65 (1.54%)  1 0/65 (0.00%)  0
Low Platelet Count = 107   0/65 (0.00%)  0 1/65 (1.54%)  1
Elevated Platelet = 456   0/65 (0.00%)  0 1/65 (1.54%)  1
Endocrine disorders     
Hypothyroidism   1/65 (1.54%)  1 0/65 (0.00%)  0
Elevated iPTH = 213   1/65 (1.54%)  1 0/65 (0.00%)  0
Elevated iPTH = 236   1/65 (1.54%)  1 0/65 (0.00%)  0
Gastrointestinal disorders     
Elevated SGOT = 103   0/65 (0.00%)  0 1/65 (1.54%)  1
Elevated SGPT = 106   1/65 (1.54%)  1 0/65 (0.00%)  0
Hepatobiliary disorders     
Gallbladder Removed   0/65 (0.00%)  0 1/65 (1.54%)  1
Infections and infestations     
Infection at Biopsy Site   1/65 (1.54%)  1 0/65 (0.00%)  0
Metabolism and nutrition disorders     
Phosphate = 5.0 MG/DL   0/65 (0.00%)  0 1/65 (1.54%)  1
iPTH = 7 PG/ML   0/65 (0.00%)  0 1/65 (1.54%)  2
Musculoskeletal and connective tissue disorders     
Back Discomfort from Car Accident   0/65 (0.00%)  0 1/65 (1.54%)  1
Right Hip Pain; Osteoarthritis Flare Up; Exacerbation   1/65 (1.54%)  1 0/65 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pituitary Tumor   0/65 (0.00%)  0 1/65 (1.54%)  1
Nervous system disorders     
Headache   1/65 (1.54%)  1 1/65 (1.54%)  1
Renal and urinary disorders     
Creatinine = 1.44 MG/DL   1/65 (1.54%)  1 0/65 (0.00%)  0
Creatinine Random Urine = 461.3   0/65 (0.00%)  0 1/65 (1.54%)  1
Skin and subcutaneous tissue disorders     
Skin Sensitivity to Adhesive Tape Post Biopsy   1/65 (1.54%)  1 0/65 (0.00%)  0
Vascular disorders     
Elevated Blood Pressure   1/65 (1.54%)  1 0/65 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. David Martins
Organization: Charles Drew University of Medicine and Science
Phone: 323-568-3353
Responsible Party: David Martins, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00948298     History of Changes
Other Study ID Numbers: IRB#08-05-2170-01
U54RR022762 ( U.S. NIH Grant/Contract )
First Submitted: July 28, 2009
First Posted: July 29, 2009
Results First Submitted: April 11, 2018
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018