Study of calcifediol treatment to improve vitamin D levels in adults with pulmonary arterial hypertension

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What is this study about?

This study focuses on patients with Pulmonary Arterial Hypertension (PAH), a condition that causes high blood pressure in the arteries of the lungs. The study will evaluate whether treatment with calcifediol, a form of vitamin D supplement, can improve the condition of patients who have very low vitamin D levels. The treatment will be compared to placebo to determine its effectiveness.

The study will test calcifediol given orally once every ten days for the first 12 weeks, followed by doses every two weeks for another 12 weeks. Two additional supplements will also be used in the study: triglycerides medium chain and alpha-tocopherol (a form of vitamin E). The total treatment period will last 24 weeks.

The main goal is to determine if this vitamin D supplementation leads to improvements in various aspects of the disease, including walking ability, heart function measurements, and overall risk level of the disease. The study will monitor how well patients tolerate the treatment and track any changes in their condition throughout the study period.

1 Initial treatment phase

You will receive vitamin D supplement (calcifediol) or placebo once every 10 days for the first 12 weeks.

The medication dose is 0.266 mg, taken by mouth.

You will continue your regular pulmonary arterial hypertension medications as prescribed by your doctor.

2 Maintenance treatment phase

From week 13 to week 24, you will receive the same medication (calcifediol or placebo) once every two weeks.

The dose remains the same at 0.266 mg, taken by mouth.

3 Medical assessments

Throughout the study, your health will be monitored through several tests:

A walking test to measure how far you can walk in 6 minutes

Blood tests to check vitamin D levels and other markers

Heart and lung function tests

Quality of life questionnaire

Regular checks of your symptoms and overall health

4 Study completion

The total duration of your participation is 24 weeks (approximately 6 months)

Your doctor will evaluate your response to treatment based on several factors including walking ability, risk assessment, and test results

Who Can Join the Study?

  • Age requirement: Must be between 18 and 75 years old, both men and women can participate
  • Must have a diagnosis of Pulmonary Arterial Hypertension (PAH) that is either:
    • Idiopathic (occurring without known cause)
    • Hereditary (inherited)
    • Drug and toxin-induced
    • Connected to connective tissue disease
  • Must be on stable PAH medication for at least 6 weeks before starting the study
  • Must have an intermediate-low or intermediate-high risk score according to current medical guidelines
  • Must have severe vitamin D deficiency (blood levels of vitamin D equal to or lower than 12 ng/ml)
  • Must be able to understand and follow study instructions
  • Must be able to participate in the entire duration of the study
  • Must provide written informed consent after receiving full information about the study

Who Cannot Join the Study?

  • Age below 18 years old
  • Pregnancy or breastfeeding
  • Other types of pulmonary hypertension not listed in inclusion criteria
  • Known allergy or hypersensitivity to vitamin D supplements
  • Current participation in other clinical trials
  • Severe kidney disease that affects vitamin D metabolism
  • History of hypercalcemia (high calcium levels in blood)
  • Active kidney stones
  • Severe liver dysfunction
  • Unable to perform the 6-minute walk test (a simple exercise test where you walk for 6 minutes)
  • Taking medications that interact with vitamin D
  • Mental conditions that could affect ability to provide informed consent
  • Any condition that, in the investigator’s opinion, makes participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital General Universitario De Valencia Valencia Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Hztbinor Vkzh dcqkllxe Barcelona Spain
Harszwyo Unrzdfvuzupwe Movzoqg Dk Voeuzvfnjt Santander Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
02.06.2025

Trial locations

Calcifediol is a form of vitamin D supplement that helps the body maintain proper calcium levels and supports bone health. In this trial, it is being studied to see if it can help improve the condition of patients with pulmonary arterial hypertension (high blood pressure in the lungs). The medication is being tested to determine if it can improve patients’ walking ability, reduce certain heart-related proteins in the blood, and improve overall heart function measurements.

Investigated diseases:

Pulmonary Arterial Hypertension (PAH) – A condition characterized by high blood pressure in the arteries that carry blood from the heart to the lungs. The disease causes the walls of the pulmonary arteries to become thick and stiff, making it harder for blood to flow through them. PAH can occur without a known cause (idiopathic), be inherited (hereditary), result from exposure to certain drugs or toxins, or develop in connection with connective tissue diseases. The narrowing of these blood vessels leads to increased work for the heart’s right side. Over time, this causes changes in physical capacity and breathing ability during daily activities.

Trial ID:
2025-521694-14-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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