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Completed

NCT Number: NCT01018849

Role of Vitamin D in Secondary Prevention of Cardiovascular Events

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cholecalciferol

Dietary Supplement

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

Other names: Vitamin D3

Placebo

Dietary Supplement

placebo by mouth every 2 months for 1 year

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

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

    Time frame: 1 year

  2. 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

  3. 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

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Nov 25, 2009
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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