Vitamin D and Immunity: Photosynthesis Versus Supplementation (IMMUNI-D)
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|ClinicalTrials.gov Identifier: NCT03609970|
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Dietary Supplement: Vitamin D Radiation: UVR (Solar simulated radiation)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Vitamin D and Immunity: Photosynthesis Versus Supplementation|
|Actual Study Start Date :||November 19, 2015|
|Actual Primary Completion Date :||April 14, 2017|
|Actual Study Completion Date :||April 14, 2017|
No Intervention: Control
Experimental: UVR (Solar simulated radiation)
Twice weekly 1.25 SED (sub-erythemal) (4 weeks)
Radiation: UVR (Solar simulated radiation)
1.25 SED Solar simulated radiation twice weekly
Experimental: Vitamin D3 supplementation
4X 1000IU cholecalciferol tablets daily (28 days)
Dietary Supplement: Vitamin D
Daily 4X 1000IU cholecalciferol
- Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated) [ Time Frame: 3 years ]Measure 25(OH)D3nmol/L via LC-MS/MS
- Changes to peripheral blood cell frequency [ Time Frame: 3 years ]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 [ Time Frame: 3 years ]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 [ Time Frame: 3 years ]Differentially regulated genes in myeloid and plasmacytoid dendritic cells in participants after vitamin D repletion via supplementation and UVR (SSR) exposure via Microarray.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609970
|Principal Investigator:||Antony Young||King's College London|