Epigenetic Memory of Vitamin D Supplementation

NCT06104111 | Unknown Phase 1

• 1 other identifier: 0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune System Diseases; Infections; Healthy Lifestyle

Keywords

Vitamin D; Epigenome; Transcriptome

Outcome Measures

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

  3 months

Study Arms (1)

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

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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

Vitamin D3 (cholecalciferol)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult (18-65 years)

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Academy of Sciences: lead

Study Sites (1)

Institute of Animal Reproduction and Food Research

Olsztyn, 10-478, Poland

RECRUITING

MeSH Terms

Conditions

Immune System Diseases; Infections

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Carsten Carlberg, PhD

CONTACT

+48-89-523-4612; c.carlberg@pan.olsztyn.pl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ERA chair of nutrigenomics

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 27, 2023
• Study Start: October 1, 2023
• Primary Completion: February 14, 2024
• Study Completion: March 30, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)