- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01570309
Vitamin D Repletion in Coronary Artery Disease
The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.
The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Jacobi Medical Center
-
Bronx, New York, United States, 10461
- Montefiore Medical Center / Weiler division
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and nonpregnant females greater than 18 years of age
- ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
- Serum 25-hydroxyvitamin D < 20 ng/ml
Exclusion Criteria:
- confinement to a nursing facility, institution or home
- GFR < 60 ml/min (by MDRD equation)
- presence of liver disease
- hypercalcemia
- NYHA class III or IV heart failure
- cardiogenic shock at time of presentation
- current planned or emergent CABG
- prior gastric or small bowel surgery
- pancreatitis
- malabsorption
- inflammatory bowel disease
- autoimmune disease
- active malignancy
- current use of > 800 IU/day of vitamin D
- Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar pill
|
Oral capsule, once a week, 12 weeks
|
Active Comparator: Ergocalciferol
50,000 units of ergocalciferol once a week for 12 weeks
|
Oral capsule, 50,000 units, once a week, 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial Function
Time Frame: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Inflammation -
Time Frame: Baseline and 12 weeks
|
Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups
|
Baseline and 12 weeks
|
Inflammation
Time Frame: Baseline to 12 weeks
|
Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups
|
Baseline to 12 weeks
|
Inflammation
Time Frame: Baseline to 12 weeks
|
Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups
|
Baseline to 12 weeks
|
Inflammation
Time Frame: Baseline to week 12
|
Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups
|
Baseline to week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Seth I Sokol, MD, Jacobi Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Inflammation
- Vitamin D Deficiency
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Ergocalciferols
Other Study ID Numbers
- AHA Award #0885041N
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaRecruitingCoronary Stenosis | Coronary Artery Bypass Grafting | Coronary Artery Disease Progression | Percutaneous Coronary RevascularizationKorea, Republic of
Clinical Trials on Ergocalciferol
-
Brigham and Women's HospitalWithdrawnNephrolithiasis | Vitamin D DeficiencyUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
King Faisal Specialist Hospital & Research CenterCompleted
-
Boston UniversityCompleted
-
University of North Carolina, Chapel HillNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruiting
-
Universidad de AntioquiaGalderma R&DCompleted
-
Galderma R&DCompletedSuperficial Basal Cell CarcinomaFinland, Austria, Belgium, France, Italy, Sweden, United Kingdom
-
Norwegian University of Science and TechnologyOslo University Hospital; Helse Stavanger HF; Haukeland University Hospital; Førde... and other collaboratorsCompletedCarcinoma, Basal Cell | Skin NeoplasmsNorway
-
University of Texas Southwestern Medical CenterRecruitingBurns | Vitamin D DeficiencyUnited States
-
Weill Medical College of Cornell UniversityCompletedObesity | Vitamin D Deficiency | Secondary HyperparathyroidismUnited States