Role of Vitamin D in Secondary Prevention of Cardiovascular Events

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Cholecalciferol; Dietary Supplement: Placebo

• Registration Number: NCT01018849
• Lead Sponsor: Creighton University

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Primary Completion: 2013-07
• Study Completion: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D (cholecalciferol)	Cholecalciferol	Subjects receive 150,000 IU of Vitamin D3 every 2 months
Placebo	Placebo	Subject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3

Primary Outcome Measures

Name	Time	Method
To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml.	1 year
To see if raising the serum 25(OH) D levels reduces the incidence of cardiovascular events in patients with coronary artery disease (CAD).	1 year

Secondary Outcome Measures

Name	Time	Method
To see if higher serum 25(OH) D levels will help in better control of blood pressure.	1 year
To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease	1 year
To compare protein expression profiles and/or MS spectrum pattern recognition, and identify differentially expressed proteins in vitamin D supplemented and placebo subjects.	1 year
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.	1 year

Trial Locations

Locations (2)

The Cardiac Center at Creighton University; 🇺🇸 Omaha, Nebraska, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States