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| Sponsor: | Thomas Jefferson University |
|---|---|
| Collaborator: |
Abbott |
| Information provided by (Responsible Party): | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT01012414 |
Purpose
The purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Chronic Kidney Disease Hypovitaminosis D Secondary Hyperparathyroidism |
Drug: paricalcitol Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Vitamin D Supplementation on Markers of Inflammation in High-Risk Cardiovascular Patients With Low Levels of Serum 25-Hydroxyvitamin D |
| Enrollment: | 12 |
| Study Start Date: | January 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: oral paricalcitol 2 mcg daily |
Drug: paricalcitol
2 mcg oral daily
Other Name: Zemplar
|
| Placebo Comparator: Placebo |
Drug: placebo
placebo
|
Vitamin D deficiency is common and has been associated with an increased risk of heart disease. In patients with the combination of kidney disease and heart disease, inflammation is thought to contribute to a high rate of cardiac events. Less is known about the effects of vitamin D supplementation on certain tests associated with inflammation in the body.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | David J Whellan, MD MHS | Thomas Jefferson University |
More Information
| Responsible Party: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT01012414 History of Changes |
| Other Study ID Numbers: | 09C.110 |
| Study First Received: | November 11, 2009 |
| Last Updated: | December 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Vitamin D Coronary Artery Disease (CAD) Chronic Kidney Disease (CKD) |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Hyperparathyroidism Hyperparathyroidism, Secondary Inflammation Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Rickets Avitaminosis Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Parathyroid Diseases Endocrine System Diseases Pathologic Processes Urologic Diseases Renal Insufficiency Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Calcium Metabolism Disorders Metabolic Diseases Vitamin D Deficiency Deficiency Diseases Malnutrition Nutrition Disorders |