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

October 2, 2023 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
    • Madrid
      • Fuenlabrada, Madrid, Spain
        • Hospital De Fuenlabrada
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario de Getafe
      • Majadahonda, Madrid, Spain
        • Hospital Puerta de Hierro
      • Mostoles, Madrid, Spain, 28933
        • Hospital Rey Juan Carlos
      • Móstoles, Madrid, Spain
        • Hospital De Mostoles
      • Valdemoro, Madrid, Spain, 28342
        • Hospital Infanta Elena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcifediol
One capsule with 15,690 IU p.o. every two weeks
Drug: Calcifediol
calcifediol treatment
Other Names:
  • vitamin D
Placebo Comparator: Placebo
One capsule with placebo p.o. every two weeks
Drug: Placebo
placebo control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiac remodeling by MRI
Time Frame: 1 year
It is a composite outcome measure. It will be analyzed by measuring the following parameters: myocardium at risk, size of infarcted myocardium, saved myocardium, ejection fraction, left ventricular telesystolic and telediastolic volumes
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in echocardiographic parameters
Time Frame: 1year
It is a composite outcome measure. It will be analyzed by measuring the following parameters: ventricular thickness and diameters, contractility abnormalities, ejection fraction.
1year
Change in mineral metabolism parameters
Time Frame: 1 year
It is a composite outcome measure. It will be analyzed by measuring plasma levels of calcidiol, FGF-23, klotho, phosphate, and PTH
1 year
Change in prognostic biomarkers levels
Time Frame: 1 year
It is a composite outcome measure. It will be analyzed by measuring plasma levels of NT-proBNP, hsCRP, MCP-1 and galectin-3
1 year
Change in lipid levels
Time Frame: 1 year
It is a composite outcome measure. It will be analyzed by measuring plasma levels of TC, LDL, HDL, TG and non-HDL Cholesterol
1 year
Change in flow mediated vasodilation
Time Frame: 1 year
1 year
Adverse event rate
Time Frame: 1.5, 3, 6, 9, 12 and 13 months
1.5, 3, 6, 9, 12 and 13 months
% of treatment compliance
Time Frame: 3, 6, 9 and 12 months
3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborators

Fondo de Investigacion Sanitaria
Spanish Society of Cardiology

Investigators

  • Principal Investigator: JOSE TUÑON, MD, PhD, IIS-FJD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimated)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJD-VITDAMI-14-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Calcifediol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe