Clinical trial NCT01018849: Role of Vitamin D in Secondary Prevention of Cardiovascular Events
Official title: Role of Vitamin D in Secondary Prevention of Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Vitamin D
Cardiac Catheterization
Cardiovascular event
Cardiovascular Disease
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml.
timeFrame: 1 year
measure: To see if raising the serum 25(OH) D levels reduces the incidence of cardiovascular events in patients with coronary artery disease (CAD).
timeFrame: 1 year
Secondary outcomes:
measure: To see if higher serum 25(OH) D levels will help in better control of blood pressure.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: To compare protein expression profiles and/or MS spectrum pattern recognition, and identify differentially expressed proteins in vitamin D supplemented and placebo subjects.
timeFrame: 1 year
measure: To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The Cardiac Center at Creighton University
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Laura Armas, MD
role: PRINCIPAL_INVESTIGATOR
References: