Effect of Calcifediol Monohydrate on Myocardial Fibrosis in Patients with Acute Myocarditis

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What is this study about?

The trial involves people who have experienced Acute myocarditis, a sudden inflammation of the heart muscle, and who also have low blood levels of vitamin D. The study tests whether giving a vitamin D supplement called calcifediol monohydrate can reduce myocardial fibrosis, which is scarring of the heart tissue that may affect how well the heart works. The supplement is taken by mouth in a set dose.

The purpose is to determine if vitamin D supplementation changes the amount of scar tissue seen after six months. Participants are randomly assigned to receive either the supplement or a placebo and are followed for six months. During the study they undergo a special heart scan called LGE CMR that shows scar tissue, blood tests for 25-OHD (the form of vitamin D measured in the blood), and a 24‑hour heart rhythm monitor that records PVC (extra heartbeats). Visits are scheduled at the start, at six weeks, and at six months to check blood levels, scan results, and any side effects.

1 baseline assessment and start medication

after joining the study you will attend a baseline visit at the study center.

during this visit a cardiac mri (cmr) scan will be performed; this scan creates detailed pictures of the heart to measure any scar tissue (myocardial fibrosis).

blood samples will be taken to measure vitamin d level, heart‑related proteins (troponin and nt‑probnp), an inflammation marker (crp), and calcium concentration.

a 24‑hour holter‑ecg monitor will be placed on your chest to record your heart rhythm continuously for one day.

you will receive the study medication, calcifediol monohydrate, to be taken orally at a dose of 266 micrograms each day.

2 daily medication administration

you will take the oral dose of 266 micrograms of calcifediol once each day for the entire study period, which lasts six months.

the medication is intended to increase your vitamin d level and is provided in tablet form that can be swallowed with water.

3 week 6 safety and laboratory visit

six weeks after starting the medication you will return for a follow‑up visit.

blood will be drawn again to check vitamin d level, troponin, nt‑probnp, crp, and calcium.

the results are used to monitor for possible excess vitamin d (hypervitaminosis d) or high calcium (hypercalcemia), which could require adjustment of the medication.

no additional imaging studies are scheduled at this visit.

4 month 6 final assessment

at six months you will undergo a final visit that includes another cardiac mri scan to evaluate the extent of myocardial fibrosis and other heart measurements.

a repeat 24‑hour holter‑ecg monitor will be used to assess any changes in heart rhythm.

blood samples will again be taken to measure vitamin d, troponin, nt‑probnp, crp, and calcium.

the information collected at this visit is compared with the baseline data to determine the effect of the vitamin d supplementation.

Who Can Join the Study?

Be 18 years old or older and have been admitted to the hospital with acute myocarditis (inflammation of the heart muscle).
Have the diagnosis confirmed by cardiac magnetic resonance imaging (CMR), a special heart scan.
Show a left ventricular ejection fraction of 40% or higher on the CMR scan, meaning the left side of the heart pumps at least 40% of its blood with each beat.
Show late gadolinium enhancement (LGE) on the CMR scan, which indicates areas of heart tissue damage.
Have a blood level of 25‑hydroxyvitamin D (25OHD) lower than 25 ng/mL, indicating low vitamin D status.

Who Cannot Join the Study?

Allergy or intolerance to calcifediol (a form of vitamin D) or any of its ingredients.
Having any type of cardiomyopathy such as dilated, hypertrophic, or arrhythmogenic (these are diseases that affect the heart muscle’s size or rhythm).
Having a congenital heart disease (a heart defect that is present from birth).
Having had an acute coronary syndrome (like a heart attack) or heart surgery within the past three months.
Being pregnant or breastfeeding.
Having cancer or any other life‑threatening illness.
Any reason that makes CMR (cardiac magnetic resonance imaging, a special heart MRI) unsafe, including allergy to gadolinium contrast media (a dye used during the scan).
Any other medical or physical condition that the study doctor decides makes participation unsuitable.
Already taking vitamin D supplements.
Currently enrolled in another clinical trial for acute myocarditis.
Unable to sign a written informed consent form or unable to give a phone number for contact.
Having hypercalcemia (blood calcium level higher than 10.5 mg/dL) or hypercalciuria (excess calcium in the urine).
Having calcium nephrolithiasis (kidney stones made of calcium).
Acute myocarditis that is complicated by hemodynamic instability (unstable blood pressure or heart function), sustained ventricular tachycardia (rapid heart rhythm originating from the lower chambers), or new problems with the heart’s electrical conduction.
Acute myocarditis caused by immune checkpoint inhibitors (certain cancer drugs).
Having eosinophilic myocarditis (a type of heart inflammation involving a specific white blood cell).
Having giant cell myocarditis (a rare, severe form of heart inflammation).
Having granulomatous disorders such as tuberculosis or sarcoidosis (diseases that form small clusters of immune cells in tissues).
Having a systemic autoimmune disorder (a disease where the immune system attacks the body’s own tissues).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hospital Universitario Hm Monteprincipe	Boadilla Del Monte	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.07.2026

Trial locations

Calcifediol monohydrate is an oral form of vitamin D that the study gives to patients with acute myocarditis who have low vitamin D levels. The medicine helps increase the amount of active vitamin D in the body, which may influence how the heart heals after inflammation. In this trial, participants take the supplement for several months, and researchers check whether it reduces scar tissue (myocardial fibrosis) in the heart as seen on MRI scans. The goal is to see if improving vitamin D status can lead to better heart recovery.

Investigated Diseases:

Myocarditis

Myocardial fibrosis – A condition where scar tissue slowly builds up in the heart muscle, making the tissue less flexible and less able to contract properly. Over time the amount of scar can increase, gradually affecting the heart’s pumping efficiency.

Acute myocarditis – An inflammation of the heart muscle that begins suddenly, often after an infection or immune response. The inflammation can cause swelling and damage to heart cells, and as the episode resolves, the heart may return to normal or retain some lingering changes.

Trial ID:

2025-523092-33-00

Protocol code:

EDIT-AM

Trial Phase:

Therapeutic confirmatory (Phase III)

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Effect of Calcifediol Monohydrate on Myocardial Fibrosis in Patients with Acute Myocarditis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?