Ongoing Clinical Trials for Vitamin D Deficiency
Currently, there are 4 ongoing clinical trials investigating treatments for vitamin D deficiency across Europe. These studies are exploring different vitamin D formulations and dosages in various patient populations, including critically ill patients, postmenopausal women, and individuals undergoing dental procedures. The trials are being conducted in Poland, Austria, and Spain.
Clinical trial locations
- Austria
- Poland
- Spain
Comparison of Two Vitamin D3 Doses (500,000 IU vs 750,000 IU) in Critically Ill Patients with Vitamin D Deficiency Receiving Continuous Renal Replacement Therapy
This trial is taking place in Poland and focuses on critically ill patients with severe vitamin D deficiency who are receiving continuous renal replacement therapy, a treatment that helps filter waste from the blood when the kidneys are not working properly.
Main inclusion criteria: Participants must be at least 18 years old and have severe vitamin D deficiency with blood levels equal to or below 12.5 ng/ml. They must be receiving continuous renal replacement therapy due to conditions such as acute kidney injury, high potassium levels, severe acid levels in the blood, fluid in the lungs, or excess fluid in the body. Patients need to have a SOFA score of at least 5, indicating significant organ failure, and must be able to receive nutrition through a feeding tube or by mouth.
Main exclusion criteria: Patients younger than 18 or older than 75 years cannot participate. Those with known allergies to vitamin D3 or its components, pregnant or breastfeeding women, and patients with high calcium levels or severe liver disease are excluded. Patients with active tuberculosis, those taking medications that interact with vitamin D3 metabolism, or those who received high-dose vitamin D supplementation in the past three months are also not eligible.
Focus and goal: The study aims to determine which of two high vitamin D3 doses—500,000 IU or 750,000 IU—is more effective at increasing vitamin D levels in critically ill patients receiving kidney support treatment. The medication being tested is Devikap, administered as oral drops through a feeding tube or by mouth. Patients receive a single dose and are monitored over 28 days, with final assessment at day 90. Blood tests track vitamin D and calcium levels, while organ function is assessed throughout the study period.
Investigational drug: Vitamin D3 (cholecalciferol) is given to help the body absorb calcium and maintain strong bones. This supplementation is particularly important for patients in intensive care who have severe deficiency and are undergoing continuous kidney treatment.
Study on High-Dose Vitamin D3 and Glycerol for Improving Wound Healing After Wisdom Tooth Removal in Patients with Vitamin D Insufficiency
This Austrian trial investigates whether high-dose vitamin D3 supplementation can improve the healing of soft tissue wounds after wisdom tooth removal in individuals with vitamin D insufficiency.
Main inclusion criteria: Participants must be between 18 and 50 years old and generally healthy individuals of Caucasian descent. They must have insufficient vitamin D levels, defined as blood levels less than 75 nmol/l or less than 30 ng/ml. Patients need to have both wisdom teeth in the upper jaw that require removal, must be able to follow instructions, and must provide written consent to participate.
Main exclusion criteria: Patients who do not have vitamin D insufficiency, those not undergoing tooth extraction, those not having wisdom teeth removed, and those unwilling to take high-dose vitamin D3 supplements cannot participate.
Focus and goal: The study compares healing after the first wisdom tooth extraction (without vitamin D3) to healing after the second extraction (with vitamin D3 supplementation). Researchers will monitor the healing process and measure substances in saliva and blood that are involved in the body’s inflammatory response, including interleukin-1b, IL-8, and myeloid-related protein-8/14. The goal is to determine if vitamin D3 can reduce inflammation and improve healing after dental surgery.
Investigational drug: Vitamin D3, combined with glycerol, is tested to see if it can help improve the healing process after dental surgery. Vitamin D3 is known for its role in bone health and immune function, and researchers want to find out if high doses taken for a short time can make healing faster or better.
Study on the Effectiveness of Cholecalciferol and Calcifediol in Treating Severe Vitamin D Deficiency in Patients
This Spanish trial compares two different forms of vitamin D—cholecalciferol (vitamin D3) and calcifediol—to determine which is more effective in treating severe deficiency.
Main inclusion criteria: Adults aged 18 years or older of both genders can participate. Patients must have severe vitamin D deficiency, defined as levels of 12 ng/ml or lower, and a body mass index between 18.5 and 34.9 kg/m². Participants must provide written consent to join the study.
Main exclusion criteria: Patients with a history of allergic reactions to vitamin D or its components, those taking medications that affect vitamin D metabolism, and individuals with kidney or liver disease that impacts vitamin D processing cannot participate. Pregnant or breastfeeding women, people with high calcium levels in the blood, those who participated in another clinical trial within the last 30 days, and anyone with malabsorption syndrome are also excluded.
Focus and goal: The 12-week study, with a primary focus on the first 6 weeks, randomly assigns participants to receive either cholecalciferol or calcifediol orally in hard capsules. The main goal is to evaluate the percentage of participants achieving vitamin D levels of 20 ng/ml or higher after treatment. The study also assesses participant satisfaction with treatment and monitors safety by tracking any side effects. This information could help improve the management of severe deficiency in the future.
Investigational drugs: Cholecalciferol (vitamin D3) helps increase vitamin D levels and is important for maintaining healthy bones and supporting the immune system. Calcifediol is a more active form that can quickly increase vitamin D levels in the body, improving bone health and overall well-being.
Study on the Required Dose of Cholecalciferol for Managing Vitamin D Deficiency in Postmenopausal Women
This Spanish trial focuses on determining the appropriate dose of cholecalciferol needed to effectively manage vitamin D levels in postmenopausal women experiencing deficiency or insufficiency.
Main inclusion criteria: Participants must be female, aged 45 years or older, and postmenopausal, meaning they have not had a menstrual period for more than one year. They must have either vitamin D deficiency (less than 20 ng/ml) or insufficiency (between 20-30 ng/ml) as measured in the blood. Women must be willing to participate, able to understand the study explanation, and provide written informed consent.
Main exclusion criteria: Men cannot participate—only women are eligible. Women who are not postmenopausal or who do not have vitamin D deficiency or insufficiency cannot join the study.
Focus and goal: Participants take Lundeos 20,000 IU soft capsules containing cholecalciferol orally. The study involves several visits where vitamin D levels in the blood are measured to evaluate treatment effectiveness. Researchers also assess participant satisfaction with the treatment. The study aims to find the best way to support women experiencing vitamin D deficiency or insufficiency after menopause, which is important because vitamin D plays a crucial role in bone health and overall well-being.
Investigational drug: Cholecalciferol, a form of vitamin D, is tested to see how effective it is for postmenopausal women with low vitamin D levels. This vitamin is important for maintaining healthy bones and supporting the immune system.
Summary
The four ongoing clinical trials for vitamin D deficiency demonstrate diverse approaches to addressing this condition across different patient populations. Two trials are being conducted in Spain, one in Poland, and one in Austria, showing European interest in optimizing vitamin D supplementation strategies.
The studies focus on various patient groups: critically ill patients receiving kidney replacement therapy, individuals undergoing wisdom tooth extraction, adults with severe deficiency, and postmenopausal women. Cholecalciferol (vitamin D3) is the most commonly investigated treatment across these trials, though one Spanish study also examines calcifediol as an alternative formulation.
Dosing strategies vary considerably, from extremely high single doses (500,000 to 750,000 IU) in intensive care settings to regular supplementation with 20,000 IU in postmenopausal women. This variation reflects the need to tailor treatment approaches based on patient condition, severity of deficiency, and clinical context. The trials collectively aim to establish more precise dosing guidelines and better understand vitamin D’s role not only in bone health but also in wound healing and recovery from critical illness.
