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RecruitingNCT06104111VitDPASUpdated Oct 27, 2023

Epigenetic Memory of Vitamin D Supplementation

A Phase 1 interventional study of Vitamin D3 in Immune System Diseases, Infections and Healthy Lifestyle, sponsored by Polish Academy of Sciences. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-27.

Sponsored by Polish Academy of Sciences · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Immune System Diseases
  • Infections
  • Healthy Lifestyle

Keywords

  • Vitamin D
  • Epigenome
  • Transcriptome
03

In context

Immune System Diseases

279 studies on the registry are indexed under Immune System Diseases; 81 are open to participants now.

This study's planned enrollment of 50 is below the median of 65 across 188 interventional studies indexed under Immune System Diseases.

Browse Immune System Diseases studies →

Lead sponsor

Polish Academy of Sciences is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

-Healthy adult (18-65 years)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Vitamin D3 (cholecalciferol)

    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

    Dietary Supplement: Vitamin D3

Interventions

  • Dietary supplementVitamin D3

    Vitamin D3 bolus at days 0, 28 and 56. Blood samples taken at days 0, 1, 28, 29, 56, 57 ad 84

    Also known as: Cholecalciferol

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Institute of Animal Reproduction and Food Research
    Olsztyn, 10-478, Poland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06104111
Lead sponsor
Polish Academy of Sciences
Responsible party
Carsten Carlberg (ERA chair of nutrigenomics, Polish Academy of Sciences) — Principal investigator
First posted
Oct 27, 2023
Start date
Oct 1, 2023
Primary completion
Feb 14, 2024 (estimated)
Completion
Mar 30, 2025 (estimated)
Last update
Oct 27, 2023

Study contacts

Carsten Carlberg, PhD
Contact
c.carlberg@pan.olsztyn.pl
+48-89-523-4612

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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