Role of Vitamin D in Secondary Prevention of Cardiovascular Events

NCT01018849 | Completed

• 1 other identifier: 08-15149
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Disease

Keywords

Vitamin D; Cardiac Catheterization; Cardiovascular event; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• To see if higher serum 25(OH) D levels will help in better control of blood pressure.

  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

• 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 obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease

  1 year

Study Arms (2)

Vitamin D (cholecalciferol)

ACTIVE COMPARATOR

Subjects receive 150,000 IU of Vitamin D3 every 2 months

Dietary Supplement: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Subject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3

Dietary Supplement: Placebo

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

cholecalciferol 150,000 IU by mouth every 2 months for 1 year

Also known as: Vitamin D3

Vitamin D (cholecalciferol)

Placebo DIETARY_SUPPLEMENT

placebo by mouth every 2 months for 1 year

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead

Study Sites (2)

The Cardiac Center at Creighton University

Omaha, Nebraska, 68131, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Laura Armas, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 25, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: May 1, 2015
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

US (2)