Vitamin D and Immunity: Photosynthesis Versus Supplementation

Vitamin D Deficiency Clinical Trial

— IMMUNI-D  

Official title:

Vitamin D and Immunity: Photosynthesis Versus Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609970
• Other study ID #: RJ115/N204
• Status: Completed
• Phase: N/A
• Start date: November 19, 2015
• Est. completion date: April 14, 2017

Study information

• Verified date: July 2018
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 14, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
Daily 4X 1000IU cholecalciferol

Radiation:
• UVR (Solar simulated radiation)
1.25 SED Solar simulated radiation twice weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes to peripheral blood cell frequency	Frequency of major peripheral immune cells (e.g. CD3+ T cells, CD3+ CD4+ T cells, CD3+ CD8+ T cells, CD19+ B cells, Natural Killer Cells, Classical, Non-classical and Intermediate Monocytes) in participants when vitamin D insufficient and sufficient. Via flow cytometry.	3 years
Secondary	Impact upon the frequency and phenotype of peripheral blood dendritic cells	Frequency of peripheral blood dendritic cells (myeloid and plasmacytoid) in individuals with insufficient vitamin D levels and following vitamin D repletion via supplementation or UVR (SSR) exposures. Assessment of markers of maturation/tolerogenicity (MFI and frequency expressing) on myeloid and plasmacytoid dendritic cells direct ex vivo and after stimulation in vitro in participants when vitamin D insufficient and sufficient.	3 years
Secondary	Gene expression in peripheral blood myeloid and plasmacytoid dendritic cells	Differentially regulated genes in myeloid and plasmacytoid dendritic cells in participants after vitamin D repletion via supplementation and UVR (SSR) exposure via Microarray.	3 years