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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
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D, UVR, Immune system

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 22, 2018
    Last Updated
    July 25, 2018
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
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    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

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    Vitamin D and Immunity: Photosynthesis Versus Supplementation

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