Role of Vitamin D in Secondary Prevention of Cardiovascular Events

Cardiovascular Disease Clinical Trial

Official title:

Role of Vitamin D in Secondary Prevention of Cardiovascular Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018849
• Other study ID #: 08-15149
• Status: Completed
• Phase: N/A
• First received: November 20, 2009
• Last updated: January 14, 2016
• Start date: July 2009
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Cholecalciferol
cholecalciferol 150,000 IU by mouth every 2 months for 1 year
• Placebo
placebo by mouth every 2 months for 1 year

Locations

Country	Name	City	State
United States	The Cardiac Center at Creighton University	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml.		1 year	No
Primary	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	No
Secondary	To see if higher serum 25(OH) D levels will help in better control of blood pressure.		1 year	No
Secondary	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	No
Secondary	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	No
Secondary	To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease		1 year	No