Vitamin D and Immunity: Photosynthesis Versus Supplementation

NCT ID: NCT03609970

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-19
• Study Completion Date: 2017-04-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

UVR (Solar simulated radiation)

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

Group Type: EXPERIMENTAL

UVR (Solar simulated radiation)

Intervention Type: RADIATION

1.25 SED Solar simulated radiation twice weekly

Vitamin D3 supplementation

4X 1000IU cholecalciferol tablets daily (28 days)

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Daily 4X 1000IU cholecalciferol

Interventions

Vitamin D

Daily 4X 1000IU cholecalciferol

Intervention Type: DIETARY_SUPPLEMENT

UVR (Solar simulated radiation)

1.25 SED Solar simulated radiation twice weekly

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antony Young

Role: PRINCIPAL_INVESTIGATOR

King's College London

Other Identifiers

RJ115/N204

Identifier Type: -

Identifier Source: org_study_id