Role of Vitamin D in Secondary Prevention of Cardiovascular Events - Full Text View

Purpose

The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.

Condition	Intervention
Cardiovascular Disease	Drug: Cholecalciferol Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Role of Vitamin D in Secondary Prevention of Cardiovascular Events

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:

To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To see if raising the serum 25(OH) D levels reduces the incidence of cardiovascular events in patients with coronary artery disease (CAD). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To see if higher serum 25(OH) D levels will help in better control of blood pressure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To perform proteomics analysis to: a) Extract total protein; b) Profile protein expression in 2-DE and /or 2-DLC and direct mass spectrometric analysis (dMS) on the serum of vitamin D supplemented and placebo subjects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To compare protein expression profiles and/or MS spectrum pattern recognition, and identify differentially expressed proteins in vitamin D supplemented and placebo subjects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2009
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vitamin D Subjects receive 150,000 IU of Vitamin D3 every 2 months	Drug: Cholecalciferol cholecalciferol 150,000 IU by mouth every 2 months for 1 year Other Name: Vitamin D3
Placebo Comparator: Placebo Subject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3	Drug: Placebo placebo by mouth every 2 months for 1 year

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female of age > 19 years at the time informed consent is signed.
Subject with a diagnosis of unstable angina (with Thrombolysis in Myocardial Infarction (TIMI) score of greater than or equal to 3) / NSTEMI or STEMI,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion
Subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.

Exclusion Criteria:

Subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin D deficiency).
Subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin D metabolism).
Subject is on an investigational drug, which is a new drug class and not part of standard ACS protocol.
Subject is taking supplements of vitamin D with doses >400 IU/day.
Subject has hypersensitivity to vitamin D products.
Subject has history of systemic lupus erythematosus (since vitamin D deficiency is common in this group27).
Subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin D28)
Subject has history of renal stones.
Subject has hypercalcemia, which is defined as serum calcium levels >10.6 mg/dl, at the time of screening.
Subject has end stage renal disease, defined as either chronic kidney disease stage V or requiring dialysis (since these patients have altered vitamin D and calcium metabolism).
Subject has systemic disease (including terminal cancer, cirrhosis, end stage COPD etc.,) with reduced (<12 months) life expectancy.
Subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study.
Subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study.
Subject is pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018849

Locations

United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
The Cardiac Center at Creighton University
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Investigators

Principal Investigator:

Laura Armas, MD

Creighton University

More Information

No publications provided

Responsible Party:	Creighton University
ClinicalTrials.gov Identifier:	NCT01018849 History of Changes
Other Study ID Numbers:	08-15149
Study First Received:	November 20, 2009
Last Updated:	March 28, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

Vitamin D
Cardiac Catheterization
Cardiovascular event
Cardiovascular Disease

Additional relevant MeSH terms:

Cardiovascular Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013