Vitamin D and Immunity: Photosynthesis Versus Supplementation

NCT03609970 | Completed

• 1 other identifier: RJ115/N204
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The optimal way to restore serum 25-hydroxyvitamin D sufficiency is currently debatable. UV irradiation through sunshine exposure promotes endogenous vitamin D synthesis, although this can also be associated with a risk of UVR-induced skin cancer. Dietary supplements represent an alternative, which are increasingly being used in clinical trials to correct deficiency. However, it is unclear whether sunshine exposure and vitamin D supplementation induce comparable changes in immune function, or whether additional UVR-induced molecules may be responsible for proposed health benefits. Several studies report an inverse correlation between exposure to UVR and immune-mediated diseases, further supporting the theory that UVR may also be protective through non vitamin-D mediated pathways. So far it has been difficult to distinguish between immune-regulation by vitamin D and other mediators induced by UVR as the downstream effects are similar. A direct comparison of the biological effects of vitamin D obtained by UVR versus supplementation has never been made. This study aims to elucidate the differences in vitamin D generated by UVR exposure versus supplementation by comparing immunological endpoints

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; UVR; Immune system

Outcome Measures

Primary Outcomes (1)

• Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated)

  Measure 25(OH)D3nmol/L via LC-MS/MS

  3 years

Secondary Outcomes (3)

• Changes to peripheral blood cell frequency

  3 years

• Impact upon the frequency and phenotype of peripheral blood dendritic cells

  3 years

• Gene expression in peripheral blood myeloid and plasmacytoid dendritic cells

  3 years

Study Arms (3)

Control

NO INTERVENTION

No intervention

UVR (Solar simulated radiation)

EXPERIMENTAL

Twice weekly 1.25 SED (sub-erythemal) (4 weeks)

Radiation: UVR (Solar simulated radiation)

Vitamin D3 supplementation

EXPERIMENTAL

4X 1000IU cholecalciferol tablets daily (28 days)

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Daily 4X 1000IU cholecalciferol

Vitamin D3 supplementation

UVR (Solar simulated radiation) RADIATION

1.25 SED Solar simulated radiation twice weekly

UVR (Solar simulated radiation)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-40
• Fitzpatrick skin type I/II
• Healthy
• Serum 25(OH)D3 \<50nmol/L

You may not qualify if:

• Serum 25(OH)D3 \>50nmol/L
• Pregnant or nursing women
• Women of child bearing age not using adequate contraception
• Are taking photosensitizing medication (i.e. causes you to be more sensitive to sunlight)
• Have had a history of skin disorders, sensitive skin, sensitivity to sunlight or skin cancer
• Have previously had an organ transplant
• Have partaken in a clinical study within the last 14 days
• Have had recent exposure to sunbeds (last 4 months) or holiday sun (including skiing)
• Are currently or have taken vitamin D supplements in the last 4 months Are asthmatic or suffer from any allergies

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Antony Young

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: August 1, 2018
• Study Start: November 19, 2015
• Primary Completion: April 14, 2017
• Study Completion: April 14, 2017
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share