Immune System DiseasesPhase 1VitDPASNCT06104111
Epigenetic Memory of Vitamin D Supplementation
A Phase 1 study testing Vitamin D3 in people with Immune System Diseases and Infections, run by Polish Academy of Sciences at 1 site in Poland.
Trial summary
The investigators will study the mechanistic details of dietary programming of the epigenome at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin D3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Diseases, Infections, Healthy Lifestyle
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2023to 30 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Healthy adult (18-65 years)
Who cannot join
- Smoker
- BMI > 28 kg/m2
- History of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or Wegener's granulomatosis
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Institute of Animal Reproduction and Food Research
Olsztyn, 10-478
Carsten Carlberg, PhD, +48-89-523-4612, c.carlberg@pan.olsztyn.pl
About this study
Official title: Investigating the Mechanisms of Epigenetic Memory at the Example of the Responsiveness of Human Immune Cells to Vitamin D
The investigators will study the mechanistic details of dietary programming of the epigenome at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin D3. They will follow a small number of healthy adult volunteers individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling. The main hypothesis of the investigators is that nutritional components, such as vitamin D3, have a direct effect on the epigenome of the different cell types of the immune system. Using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory.
Read the detailed description
Exposure to dietary molecules during adulthood creates an epigenetic memory in immune cells affecting disease risk in later years of life. Many nutritional molecules have a direct effect on the human genome and/or epigenome, since they (or their metabolites) activate transcription factors or chromatin modifiers. This process is the mechanistic basis of the discipline nutrigenomics. Thus, the daily diet of humans leads to changes in the transcriptome and epigenome of many tissues and cell types. In this way, many physiological functions of the human body, such as a well-responding immune system, are influenced by diet. Some of these effects are not only transient but may lead to persistent changes of the epigenome in many different tissues. However, the mechanistic details of this dietary programming of the epigenome are not well understood. Therefore, in this study, the investigators will study this process at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin D3. They will use the approach to follow a small but sufficient number of healthy adult volunteers (based on power calculation of self-controlled longitudinal studies) individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling, instead of investigating only few parameters from a large number of participants for statistical modeling. The main hypothesis of the investigators is that nutritional components, such as vitamin D3, have a direct effect on the epigenome of the different cell types of the immune system. Using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory.
- Conditions
- Immune System Diseases, Infections, Healthy Lifestyle
- Being tested
- Vitamin D3
- Keywords
- Vitamin D, Epigenome, Transcriptome
- Medical subject headings
- Immune System Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Vitamin D3 bolus at days 0, 28 and 56. Blood samples taken at days 0, 1, 28, 29, 56, 57 ad 84
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (cholecalciferol) | Experimental | 1000 IU vitamin D3 (cholecalciferol)/kg body mass will be taken in form of individual number of pills (4000 IU each, e.g. 20 pills for a person of 80 kg) in the morning together with a breakfast at days 0, 28 and 56 Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D-induced changes in the epigenome of PBMCs describing the individual -specific vitamin D response index of the study participants
A bolus of vitamin D3 (monthly dose, taken once a month in three repeats) will change the epigenome (and transcriptome) of PBMCs of the study participants in an individual-specific way. These measurements will allow to distinguish the molecular response of the study participants, in order to segregate them into high, mid and low responders to vitamin D. This classification will lead to individual-specific recommendations for daily vitamin D3 supplementation in following winters. Moreover, the molecular investigations will allow a better understanding of the molecular mechanisms of vitamin D responsiveness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Oct 2023
- Primary completion14 Feb 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Carlberg, Polish Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104111
- Sponsor's protocol ID
- 0001
- Acronym
- VitDPAS
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Mechanisms of Epigenetic Memory at the Example of the Responsiveness of Human Immune Cells to Vitamin D
- ClinicalTrials.gov ID
- NCT06104111
- Acronym / sponsor ID
- VitDPAS / 0001
- Conditions
- Immune System Diseases, Infections, Healthy Lifestyle
- Keywords
- Vitamin D, Epigenome, Transcriptome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Polish Academy of SciencesUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will study the mechanistic details of dietary programming of the epigenome at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin D3. They will follow a small number of healthy adult volunteers individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling. The main hypothesis of the investigators is that nutritional components, such as vitamin D3, have a direct effect on the epigenome of the different cell types of the immune system. Using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory.
Detailed description
Exposure to dietary molecules during adulthood creates an epigenetic memory in immune cells affecting disease risk in later years of life. Many nutritional molecules have a direct effect on the human genome and/or epigenome, since they (or their metabolites) activate transcription factors or chromatin modifiers. This process is the mechanistic basis of the discipline nutrigenomics. Thus, the daily diet of humans leads to changes in the transcriptome and epigenome of many tissues and cell types. In this way, many physiological functions of the human body, such as a well-responding immune system, are influenced by diet. Some of these effects are not only transient but may lead to persistent changes of the epigenome in many different tissues. However, the mechanistic details of this dietary programming of the epigenome are not well understood. Therefore, in this study, the investigators will study this process at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin D3. They will use the approach to follow a small but sufficient number of healthy adult volunteers (based on power calculation of self-controlled longitudinal studies) individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling, instead of investigating only few parameters from a large number of participants for statistical modeling. The main hypothesis of the investigators is that nutritional components, such as vitamin D3, have a direct effect on the epigenome of the different cell types of the immune system. Using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (cholecalciferol) | Experimental | Dietary Supplement: Vitamin D31000 IU vitamin D3 (cholecalciferol)/kg body mass will be taken in form of individual number of pills (4000 IU each, e.g. 20 pills for a person of 80 kg) in the morning together with a breakfast at days 0, 28 and 56 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Healthy adult (18-65 years)
Key exclusion criteria (3 listed)
- Smoker
- BMI > 28 kg/m2
- History of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or Wegener's granulomatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: CholecalciferolVitamin D3 bolus at days 0, 28 and 56. Blood samples taken at days 0, 1, 28, 29, 56, 57 ad 84 | Dietary supplement | Vitamin D3 (cholecalciferol) |
Primary outcome
Vitamin D-induced changes in the epigenome of PBMCs describing the individual -specific vitamin D response index of the study participants
Time frame: 3 months
A bolus of vitamin D3 (monthly dose, taken once a month in three repeats) will change the epigenome (and transcriptome) of PBMCs of the study participants in an individual-specific way. These measurements will allow to distinguish the molecular response of the study participants, in order to segregate them into high, mid and low responders to vitamin D. This classification will lead to individual-specific recommendations for daily vitamin D3 supplementation in following winters. Moreover, the molecular investigations will allow a better understanding of the molecular mechanisms of vitamin D responsiveness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 in people with Immune System Diseases and Infections, run by Polish Academy of Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carsten Carlberg, PhD (+48-89-523-4612, c.carlberg@pan.olsztyn.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D-induced changes in the epigenome of PBMCs describing the individual -specific vitamin D response index of the study participants (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.