Fakultni Nemocnice Plzen
Plzen, Czechia
Recruiting
Study on Vitamin D3 (Colecalciferol) Supplementation in Young Adults and Seniors to Compare Effects and Develop Age-Specific Models
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of Vitamin D3 supplementation in healthy individuals. The study involves two groups of participants: young adults aged 20 to 27 and seniors aged 65 to 85. The treatment being tested is a solution called Vigantol, which contains colecalciferol, also known as Vitamin D3. This vitamin is important for maintaining healthy bones and supporting the immune system.
The purpose of the study is to compare how effective Vitamin D3 supplementation is in these two age groups when given the same dosage. Researchers aim to develop a model for effective supplementation tailored to each age group based on the differences observed. Participants will take the Vitamin D3 solution orally over a period of time, and their health will be monitored to assess the impact of the supplementation.
Throughout the study, the main focus will be on measuring levels of a specific form of Vitamin D in the blood, known as Serum 25-hydroxycholecalciferol. Additionally, other forms of Vitamin D in the blood, such as Serum 24,25-dihydroxycholecalciferol and Serum 3-epi-25-hydroxycholecalciferol, will also be measured to provide a comprehensive understanding of how the body processes the vitamin. The study is expected to continue until 2027, providing valuable insights into the benefits of Vitamin D3 for different age groups.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Participants must be healthy individuals of any gender who agree to participate and do not have any conditions that would exclude them from the study.
- Participants must be between the ages of 20 to 27 or 65 to 85 years old.
- Women who can have children must use highly effective contraception during the study. This means using methods that are very reliable in preventing pregnancy.
- Participants must have a Body Mass Index (BMI) of at least 18.5 and less than 30. BMI is a measure that uses your height and weight to work out if your weight is healthy.
- Participants must be of the White race.
- Participants must be healthy or have a stable chronic disease that is not listed in the exclusion criteria. A stable chronic disease is a long-term condition that is not currently causing any major health issues.
Who cannot join the trial?
2 criteria
- Participants must be part of the healthy population. This means they should not have any ongoing illnesses or medical conditions.
- Participants should not be part of a vulnerable population. This refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs
Vitamin D3 is a supplement that helps your body absorb calcium, which is important for maintaining strong bones. In this clinical trial, Vitamin D3 is being used to see how effective it is in improving bone health in both young adults and older people. The study aims to find out if there are differences in how well Vitamin D3 works for these two age groups and to develop a better way to use this supplement for each group.
What is already known about the treatment
Vitamin D3 – Vitamin D3 is typically administered orally in the form of capsules or tablets. It is currently well-established in medical literature as a supplement to support bone health and immune function, particularly in populations with limited sun exposure. The main therapeutic indication for Vitamin D3 is to maintain adequate levels of vitamin D in the body, which is crucial for calcium absorption and bone health. At the molecular level, Vitamin D3 is converted in the body to its active form, calcitriol, which then helps regulate calcium and phosphate balance in the bloodstream. It is classified pharmacologically as a vitamin supplement.
Investigated diseases
Healthy Population – This term refers to individuals who do not have any diagnosed diseases or medical conditions. In a healthy population, bodily systems function normally, and there are no symptoms of illness. The immune system operates effectively to protect against infections and diseases. Metabolic processes, such as digestion and energy production, occur without complications. Individuals in a healthy population typically maintain a balanced state of physical and mental well-being. Regular physical activity, a balanced diet, and adequate rest contribute to sustaining this state of health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519747-15-00Protocol codeD3-2024Estimated enrolment150 patientsSponsorFakultni Nemocnice Plzen
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