Fakultni Nemocnice Plzen
Plzen, Czechia
Not yet recruiting
Study on Vitamin D3 (Colecalciferol) Supplementation in Young Adults and Seniors to Develop Age-Specific Models for Healthy Individuals
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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: young adults aged 20 to 27 and seniors aged 65 to 85. The treatment being tested is a medication called Vigantol, which contains the active substance colecalciferol, commonly known as Vitamin D3. Participants will receive this treatment in the form of oral drops.
The purpose of the study is to compare how effective Vitamin D3 supplementation is in young adults versus seniors. By doing this, researchers aim to develop a model for effective Vitamin D3 supplementation tailored to each age group. The study will observe participants over a period of time to see how their bodies respond to the same dosing schedule of Vitamin D3.
Throughout the study, researchers will monitor specific markers in the blood, such as Serum 25-hydroxycholecalciferol, to assess the impact of the supplementation. These markers help in understanding how Vitamin D3 is processed in the body. The study will also look at other related markers to gather more information on the effects of the treatment. The findings from this study could help improve Vitamin D3 supplementation strategies for different age groups.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Individuals who agree to participate and do not have any conditions that would exclude them from the study.
- Age between 20-27 years or 65-85 years.
- Women who can have children must use highly effective birth control during the study.
- Body Mass Index (BMI) between 18.5 and less than 30. BMI is a measure of body fat based on height and weight.
- Participants must be of the White race.
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 need special protection or care, such as those with severe health issues or 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 study, Vitamin D3 is being used to see how well it works in improving bone health in both young adults and older people. The researchers want to find out if there are any differences in how effective Vitamin D3 is for these two age groups, and to develop a better way to use this supplement for each group based on what they learn.
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. The main therapeutic indication for Vitamin D3 is to prevent or treat Vitamin D deficiency, which can lead to bone disorders such as rickets in children and osteomalacia in adults. At the molecular level, Vitamin D3 works by helping the body absorb calcium and phosphorus, which are essential for building and maintaining strong bones. 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 progression of health in such individuals typically involves maintaining normal physiological functions and preventing the onset of diseases. Factors such as age, lifestyle, and genetics can influence the overall health status. The focus is often on maintaining wellness through balanced nutrition, regular physical activity, and preventive healthcare measures. The study of healthy populations can provide insights into the prevention of diseases and the promotion of long-term health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511889-36-01Protocol codeD3-2024Estimated enrolment150 patientsSponsorFakultni Nemocnice Plzen
sourced from the EU Clinical Trials Register and site verification
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