NCT02548364

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

7.6 years

First QC Date

July 6, 2015

Last Update Submit

October 2, 2023

Conditions

Myocardial Infarction

Keywords

Vitamin DMyocardial InfarctionVentricular remodelingBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in cardiac remodeling by MRI

    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 Outcomes (7)

  • Change in echocardiographic parameters

    1year

  • Change in mineral metabolism parameters

    1 year

  • Change in prognostic biomarkers levels

    1 year

  • Change in lipid levels

    1 year

  • Change in flow mediated vasodilation

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Calcifediol

EXPERIMENTAL

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

Drug: Calcifediol

Placebo

PLACEBO COMPARATOR

One capsule with placebo p.o. every two weeks

Drug: Placebo

Interventions

CalcifediolDRUG

calcifediol treatment

Also known as: vitamin D
Calcifediol
PlaceboDRUG

placebo control group

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital de Fuenlabrada

Fuenlabrada, Madrid, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

Location

Hospital de Móstoles

Móstoles, Madrid, Spain

Location

Hospital Infanta Elena

Valdemoro, Madrid, 28342, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Publications (1)

  • Tunon J, Gonzalez-Hernandez I, Llanos-Jimenez L, Alonso-Martin J, Escudier-Villa JM, Tarin N, Cristobal C, Sanz P, Pello AM, Acena A, Carda R, Orejas M, Tomas M, Beltran P, Calero Rueda M, Marcos E, Serrano-Antolin JM, Gutierrez-Landaluce C, Jimenez R, Cabezudo J, Curcio A, Peces-Barba G, Gonzalez-Parra E, Munoz-Siscart R, Gonzalez-Casaus ML, Lorenzo A, Huelmos A, Goicolea J, Ibanez B, Hernandez G, Alonso-Pulpon LM, Farre J, Lorenzo O, Mahillo-Fernandez I, Egido J. Design and rationale of a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of vitamin D on ventricular remodelling in patients with anterior myocardial infarction: the VITamin D in Acute Myocardial Infarction (VITDAMI) trial. BMJ Open. 2016 Aug 5;6(8):e011287. doi: 10.1136/bmjopen-2016-011287.

    PMID: 27496232DERIVED

MeSH Terms

Conditions

Myocardial InfarctionVentricular Remodeling

Interventions

CalcifediolVitamin D

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

HydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • JOSE TUÑON, MD, PhD

    IIS-FJD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

September 14, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Locations

ES(7)