Vitamin D and Immunity: Photosynthesis Versus Supplementation (IMMUNI-D)
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D
UVR (Solar simulated radiation)
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D, UVR, Immune system
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
UVR (Solar simulated radiation)
Vitamin D3 supplementation
Arm Description
No intervention
Twice weekly 1.25 SED (sub-erythemal) (4 weeks)
4X 1000IU cholecalciferol tablets daily (28 days)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03609970
First Posted
June 22, 2018
Last Updated
July 25, 2018
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03609970
Brief Title
Vitamin D and Immunity: Photosynthesis Versus Supplementation
Acronym
IMMUNI-D
Official Title
Vitamin D and Immunity: Photosynthesis Versus Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 19, 2015 (Actual)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
April 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, UVR, Immune system
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
UVR (Solar simulated radiation)
Arm Type
Experimental
Arm Description
Twice weekly 1.25 SED (sub-erythemal) (4 weeks)
Arm Title
Vitamin D3 supplementation
Arm Type
Experimental
Arm Description
4X 1000IU cholecalciferol tablets daily (28 days)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Daily 4X 1000IU cholecalciferol
Intervention Type
Radiation
Intervention Name(s)
UVR (Solar simulated radiation)
Intervention Description
1.25 SED Solar simulated radiation twice weekly
Primary Outcome Measure Information:
Title
Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated)
Description
Measure 25(OH)D3nmol/L via LC-MS/MS
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Changes to peripheral blood cell frequency
Description
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.
Time Frame
3 years
Title
Impact upon the frequency and phenotype of peripheral blood dendritic cells
Description
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.
Time Frame
3 years
Title
Gene expression in peripheral blood myeloid and plasmacytoid dendritic cells
Description
Differentially regulated genes in myeloid and plasmacytoid dendritic cells in participants after vitamin D repletion via supplementation and UVR (SSR) exposure via Microarray.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antony Young
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D and Immunity: Photosynthesis Versus Supplementation
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