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 study about?

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.

1 joining the study

Upon joining the study, participants will be informed about the purpose and procedures involved. The study aims to compare the effectiveness of vitamin D3 supplementation in young adults and seniors.

Participants will be divided into two age groups: 20-27 years and 65-85 years. The study will focus on healthy individuals with a body mass index (BMI) between 18.5 and less than 30.

2 medication administration

Participants will receive Vigantol 0.5 mg/ml oral drops, which is a solution containing colecalciferol (vitamin D3).

The medication will be taken orally. The dosage, frequency, and duration of administration will be explained during the study, ensuring participants understand how to take the medication correctly.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess the levels of vitamin D in their blood. The primary focus will be on serum 25-hydroxycholecalciferol levels.

Secondary assessments will include measuring serum 24,25-dihydroxycholecalciferol and serum 3-epi-25-hydroxycholecalciferol levels.

4 completion of the study

The study is expected to conclude by April 30, 2026. Participants will be informed about the outcomes and any findings related to the effectiveness of vitamin D3 supplementation in different age groups.

Upon completion, participants may receive information on how the results could contribute to developing effective supplementation models for each age group.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fakultni Nemocnice Plzen	Plzen	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	01.09.2024

Trial locations

Investigated drugs:

Colecalciferol

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.

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 ID:

2024-511889-36-01

Protocol code:

D3-2024

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Vitamin D3 (Colecalciferol) Supplementation in Young Adults and Seniors to Develop Age-Specific Models for Healthy Individuals

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