Clinical trial NCT03609970: Vitamin D and Immunity: Photosynthesis Versus Supplementation
Official title: Vitamin D and Immunity: Photosynthesis Versus Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
UVR
Immune system
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated)
timeFrame: 3 years
Secondary outcomes:
measure: Changes to peripheral blood cell frequency
timeFrame: 3 years
measure: Impact upon the frequency and phenotype of peripheral blood dendritic cells
timeFrame: 3 years
measure: Gene expression in peripheral blood myeloid and plasmacytoid dendritic cells
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: King's College London
name: Antony Young
role: PRINCIPAL_INVESTIGATOR
References: