Study on Vitamin D3 (Colecalciferol) Supplementation in Young Adults and Seniors to Compare Effects and Develop Age-Specific Models

1 1 1 1

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 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.

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 or those with stable chronic conditions not listed in the exclusion criteria.

2 initial assessment

An initial health assessment will be conducted to ensure eligibility. This includes checking the Body Mass Index (BMI) to confirm it is between 18.5 and less than 30.

Women of childbearing potential must agree to use highly effective contraception throughout the study.

3 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 as per the dosing schedule provided by the study team. The exact dosage and frequency will be explained during the study.

4 monitoring and follow-up

Regular monitoring will be conducted to measure the levels of Serum 25-hydroxycholecalciferol, which is the primary endpoint of the study.

Secondary endpoints include measuring Serum 24,25-dihydroxycholecalciferol and Serum 3-epi-25-hydroxycholecalciferol levels.

5 completion of the study

The study is expected to conclude by April 30, 2027. Participants will be informed about the outcomes and any further steps if necessary.

The results will help develop an effective vitamin D3 supplementation model for different age groups based on the findings.

Who Can Join the Study?

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 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 be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Fakultni Nemocnice Plzen	Plzen	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.09.2025

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 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.

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 ID:

2024-519747-15-00

Protocol code:

D3-2024

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Vitamin D3 (Colecalciferol) Supplementation in Young Adults and Seniors to Compare Effects and Develop Age-Specific Models

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?