Myocardial InfarctionPhase 3VITDAMINCT02548364
Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)
A Phase 3 study testing Calcifediol in people with Myocardial Infarction, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 7 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Calcifediol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 7 sitesSpain
- Study dates
- Oct 2015to May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years and maximum 85 years.
- Anterior myocardial infarction
- Sign informed consent
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital de Fuenlabrada
Fuenlabrada, Madrid
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Fundación Jiménez Díaz
Madrid, 28040
Hospital Puerta de Hierro
Majadahonda, Madrid
Hospital Rey Juan Carlos
Móstoles, Madrid, 28933
Hospital de Móstoles
Móstoles, Madrid
Hospital Infanta Elena
Valdemoro, Madrid, 28342
About this study
Official title: 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.
- Conditions
- Myocardial Infarction
- Being tested
- Calcifediol, Placebo
- Keywords
- Vitamin D, Myocardial Infarction, Ventricular remodeling, Biomarkers
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcifediolDrug
Also called vitamin D
calcifediol treatment
PlaceboDrug
placebo control group
| Study group | Role | What they receive |
|---|---|---|
| Calcifediol | Experimental | One capsule with 15,690 IU p.o. every two weeks Receives: Drug: Calcifediol |
| Placebo | Placebo comparator | One capsule with placebo p.o. every two weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (7)
Change in echocardiographic parameters
It is a composite outcome measure. It will be analyzed by measuring the following parameters: ventricular thickness and diameters, contractility abnormalities, ejection fraction.
Measured: 1year
Change in mineral metabolism parameters
It is a composite outcome measure. It will be analyzed by measuring plasma levels of calcidiol, FGF-23, klotho, phosphate, and PTH
Measured: 1 year
Change in prognostic biomarkers levels
It is a composite outcome measure. It will be analyzed by measuring plasma levels of NT-proBNP, hsCRP, MCP-1 and galectin-3
Measured: 1 year
Change in lipid levels
It is a composite outcome measure. It will be analyzed by measuring plasma levels of TC, LDL, HDL, TG and non-HDL Cholesterol
Measured: 1 year
Change in flow mediated vasodilation
Measured: 1 year
Adverse event rate
Measured: 1.5, 3, 6, 9, 12 and 13 months
% of treatment compliance
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2023
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Spanish Society of Cardiology
- Responsible party
- Sponsor
- Investigators
- JOSE TUÑON, MD, PhD, Principal investigator, IIS-FJD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548364
- Sponsor's protocol ID
- FJD-VITDAMI-14-01
- Acronym
- VITDAMI
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2015
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Tunon J, Rodriguez-Lopez C, Balaguer J, Gomez-Talavera S, Rojas A, Salamanca J, Garcia CL, Esteve-Pastor MA, Laffond A, Herrera C, Escudier-Villa JM, Orejas M, Tomas M, Alvarez ML, Tomeo MA, Llanos-Jimenez L, Gonzalez-Lorenzo O, Kallmeyer A, Ibanez B, Gonzalez-Casaus ML, Hernandez G, Espadas C, Lorenzo O, Mahillo-Fernandez I, Egido J, Sanchez PL, Marin F, Alfonso F. Vitamin D in the prevention of left ventricular remodelling after an acute myocardial infarction: a randomized clinical trial. Sci Rep. 2026 Apr 6;16(1):16486. doi: 10.1038/s41598-026-45330-6.
PubMed 41942544Tunon 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.
PubMed 27496232
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02548364
- Acronym / sponsor ID
- VITDAMI / FJD-VITDAMI-14-01
- Conditions
- Myocardial Infarction
- Keywords
- Vitamin D, Myocardial Infarction, Ventricular remodeling, Biomarkers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Spanish Society of Cardiology
- Study start
- Oct 2015
- Primary completion
- May 2023 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcifediol | Experimental | Drug: CalcifediolOne capsule with 15,690 IU p.o. every two weeks |
| Placebo | Placebo comparator | Drug: PlaceboOne capsule with placebo p.o. every two weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 40 years and maximum 85 years.
- Anterior myocardial infarction
- Sign informed consent
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcifediolAlso: vitamin Dcalcifediol treatment | Drug | Calcifediol |
| Placeboplacebo control group | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Change in echocardiographic parameters
Time frame: 1year
Change in mineral metabolism parameters
Time frame: 1 year
Change in prognostic biomarkers levels
Time frame: 1 year
Change in lipid levels
Time frame: 1 year
Change in flow mediated vasodilation
Time frame: 1 year
Adverse event rate
Time frame: 1.5, 3, 6, 9, 12 and 13 months
% of treatment compliance
Time frame: 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 41942544Tunon J, Rodriguez-Lopez C, Balaguer J, Gomez-Talavera S, Rojas A, Salamanca J, Garcia CL, Esteve-Pastor MA, Laffond A, Herrera C, Escudier-Villa JM, Orejas M, Tomas M, Alvarez ML, Tomeo MA, Llanos-Jimenez L, Gonzalez-Lorenzo O, Kallmeyer A, Ibanez B, Gonzalez-Casaus ML, Hernandez G, Espadas C, Lorenzo O, Mahillo-Fernandez I, Egido J, Sanchez PL, Marin F, Alfonso F. Vitamin D in the prevention of left ventricular remodelling after an acute myocardial infarction: a randomized clinical trial. Sci Rep. 2026 Apr 6;16(1):16486. doi: 10.1038/s41598-026-45330-6.
- Derived from this study: PubMed 27496232Tunon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE TUÑON, MD, PhD principal investigator
IIS-FJD
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcifediol in people with Myocardial Infarction, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac remodeling by MRI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.