Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2023-05-31

Brief Summary

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To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma levels of several prognostic biomarkers and on endothelial function after an anterior myocardial infarction.

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Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcifediol

One capsule with 15,690 IU p.o. every two weeks

Group Type EXPERIMENTAL

Calcifediol

Intervention Type DRUG

calcifediol treatment

Placebo

One capsule with placebo p.o. every two weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo control group

Interventions

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Calcifediol

calcifediol treatment

Intervention Type DRUG

Placebo

placebo control group

Intervention Type DRUG

Other Intervention Names

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vitamin D

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 40 years and maximum 85 years.
* Anterior myocardial infarction
* Sign informed consent

Exclusion Criteria

* Death during the index event
* Age younger than 40 or older than 85 years
* Previous Infarction
* More than 7 days in hospitalization
* Systemic inflammatory or autoimmune disease
* Concomitant disorders limiting survival
* Concomitant cardiomyopathy
* Left ventricular hypertrophy \> 16mm in females and \> 17mm in males
* eGFR\<45
* LVEF\<30
* Incomplete revascularization
* Valvular prosthesis
* Aortic stenosis with mean gradient\> 25 mmHg
* Moderate or severe valvular regurgitation
* Hypersensitivity or intolerance vitamin D supplement o excipient
* Blood Calcium \>10.5 mg/dl
* Inability to follow.
* Difficulty in treatment compliance
* Contraindication for MRI, including indication to place a cardiac device
* Indication of therapy with vitamin D. Patient desires to take vitamin D.
* Drugs or conditions that interfere with the pharmacokinetics of calcifediol

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No