Role of Vitamin D in Secondary Prevention of Cardiovascular Events

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01018849
First received: November 20, 2009
Last updated: March 28, 2013
Last verified: March 2013

November 20, 2009
March 28, 2013
July 2009
July 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018849 on ClinicalTrials.gov Archive Site
  • To see if higher serum 25(OH) D levels will help in better control of blood pressure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
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Role of Vitamin D in Secondary Prevention of Cardiovascular Events
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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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Cardiovascular Disease
  • Drug: Cholecalciferol
    cholecalciferol 150,000 IU by mouth every 2 months for 1 year
    Other Name: Vitamin D3
  • Drug: Placebo
    placebo by mouth every 2 months for 1 year
  • Active Comparator: Vitamin D
    Subjects receive 150,000 IU of Vitamin D3 every 2 months
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Subject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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July 2013   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018849
08-15149
Not Provided
Creighton University
Creighton University
Not Provided
Principal Investigator: Laura Armas, MD Creighton University
Creighton University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP