Vitamin D DeficiencyIMMUNI-DNCT03609970
Vitamin D and Immunity: Photosynthesis Versus Supplementation
A study testing Vitamin D and UVR (Solar simulated radiation) in people with Vitamin D Deficiency, run by Guy's and St Thomas' NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D and UVR (Solar simulated radiation)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2015to 14 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40
- Fitzpatrick skin type I/II
- Healthy
- Serum 25(OH)D3 <50nmol/L
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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
- Being tested
- Vitamin D, UVR (Solar simulated radiation)
- Keywords
- Vitamin D, UVR, Immune system
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Daily 4X 1000IU cholecalciferol
UVR (Solar simulated radiation)Radiation
1.25 SED Solar simulated radiation twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| UVR (Solar simulated radiation) | Experimental | Twice weekly 1.25 SED (sub-erythemal) (4 weeks) Receives: Radiation: UVR (Solar simulated radiation) |
| Vitamin D3 supplementation | Experimental | 4X 1000IU cholecalciferol tablets daily (28 days) Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start19 Nov 2015
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antony Young, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609970
- Sponsor's protocol ID
- RJ115/N204
- Acronym
- IMMUNI-D
- Status last verified
- Jul 2018
- First submitted
- 22 Jun 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Immunity: Photosynthesis Versus Supplementation
- ClinicalTrials.gov ID
- NCT03609970
- Acronym / sponsor ID
- IMMUNI-D / RJ115/N204
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, UVR, Immune system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| UVR (Solar simulated radiation) | Experimental | Radiation: UVR (Solar simulated radiation)Twice weekly 1.25 SED (sub-erythemal) (4 weeks) |
| Vitamin D3 supplementation | Experimental | Dietary Supplement: Vitamin D4X 1000IU cholecalciferol tablets daily (28 days) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-40
- Fitzpatrick skin type I/II
- Healthy
- Serum 25(OH)D3 <50nmol/L
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DDaily 4X 1000IU cholecalciferol | Dietary supplement | Vitamin D3 supplementation |
| UVR (Solar simulated radiation)1.25 SED Solar simulated radiation twice weekly | Radiation | UVR (Solar simulated radiation) |
Primary outcome
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
3 secondary outcomes
Changes to peripheral blood cell frequency
Time frame: 3 years
Impact upon the frequency and phenotype of peripheral blood dendritic cells
Time frame: 3 years
Gene expression in peripheral blood myeloid and plasmacytoid dendritic cells
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: No
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Strategies for Proactive Health in People With Kidney Function Decline
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The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antony Young principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and UVR (Solar simulated radiation) in people with Vitamin D Deficiency, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.