Not yet recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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
Step 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 trial?

11 criteria

Age requirement: Must be between 18 and 75 years old, both men and women can participate
check
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 trial?

13 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
El Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria, Spain
Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital Del Mar
Barcelona, Spain

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Calcifediol - A prescription form of vitamin D (25-hydroxyvitamin D3) that is administered orally once every ten days initially, followed by bi-weekly dosing. This medication is being studied in clinical trials for treating Pulmonary Arterial Hypertension (PAH), where it may help improve exercise capacity and clinical outcomes in patients with vitamin D deficiency. As a vitamin D analog, it works by regulating calcium absorption and homeostasis in the body, while also potentially affecting blood vessel function and inflammation processes. Calcifediol belongs to the vitamin D analog pharmacological class and is currently approved for treating vitamin D deficiency, while its use in PAH represents an investigational application being evaluated through clinical research.

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.