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Vitamin D and Immunity: Photosynthesis Versus Supplementation (IMMUNI-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03609970
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D Radiation: UVR (Solar simulated radiation) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
No Intervention: Control
No intervention
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Antony Young King's College London
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03609970    
Other Study ID Numbers: RJ115/N204
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Vitamin D
UVR
Immune system
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents