Vitamin d DeficiencyVDSSNCT05654818
Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects
A study testing Vitamin D in people with Vitamin d Deficiency, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Vitamin D deficiency is associated with the risk of developing MS. Vitamin D treatment has therefore been tested as a background treatment for this pathology, with a seemingly modest clinical effect. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin d Deficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2023to 10 Oct 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Women of childbearing potential must have effective contraception during the study period. Effective contraception is defined by a low failure rate (less than 1% per year) when used correctly and consistently, such as implants, injectables, oral contraceptives, IUDs, abstinence, or partner vasectomy. A urine pregnancy test will be performed at inclusion.
Who cannot join
- The subject is participating in another therapeutic study, or is in a period of exclusion determined by a previous study
- The subject is unable to express their consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Pregnant or breastfeeding
- Infectious disease or vaccination within previous 3 months
Show all 16Show fewer
- Chronic psychiatric disease, or disease that, in the opinion of the investigator ,may put the patient at risk or affect compliance.
- Chronic inflammatory or dysimmune disease or subject on immunomodulatory or immunosuppressive therapy (including corticosteroids) within the last 3 months.
- Uncontrolled epilepsy.
- Known vitamin D deficiency secondary to active or other digestive disease (celiac disease, IBD, gastrectomy or bypass, cirrhosis, short bowel syndrome, nephrotic syndrome, hyperthyroidism, hypoparathyroidism, cancer, granulomatous pathology, lymphoma, rickettsiosis).
- History of hypercalcemia, osteopenia or osteoporosis, urinary lithiasis, heart rhythm disorders.
- Pathology requiring a daily intake of more than 1 gram of Calcium.
- Contraindication to vitamin D3 treatment as mentioned on the VIDAL documentation of UVEDOSE.
- Treatment affecting vitamin D metabolism other than corticosteroids: anti-epileptic drugs [phenobarbital, primidone, phenytoin], rifampicin, isoniazid, ketoconazole, 5-FU and leucovorin, thiazide diuretic.
- Active vitamin supplementation or dietary supplements rich in vitamin D.
- Present or past neurological symptoms that may suggest an undiagnosed inflammatory neurological pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects: Randomized, Single-center, Double-blind Trial
Vitamin D deficiency is associated with the risk of developing MS. Vitamin D treatment has therefore been tested as a background treatment for this pathology, with a seemingly modest clinical effect. Indeed, the first therapeutic trials using high doses of vitamin D (SOLAR and CHOLINE) did not show a significant effect on short-term relapses. However, these two studies showed a significant decrease in the radiological activity of MS on MRI, suggesting a significant immunomodulatory efficacy but a weak clinical benefit in the short term.
Vitamin D has a pleiotropic effect on the immune system inducing overall immunomodulation through transcriptomic modulations, under the control of many individual genetic factors. However, in vivo, only one therapeutic trial has compared the immunological effect of Vitamin D in healthy subjects and in patients with a first demyelinating episode. Analysis of PBMC by flow cytometric cell sorting based on a very small number of markers (CD3, CD8, IL-17, IFN-g) did not find any significant quantitative modulation of Th17 or of their production of IL-10, IL-17 and IFN-g after treatment with Vitamin D measured by ELISA. However, the evolution of anti-inflammatory lymphocyte populations has not been evaluated. A few in vitro studies suggest that the effect of vitamin D may be incomplete on the lymphocytes of MS patients.
The study investigators will use an immunological FACS approach to describe activation markers and measure the intensity of changes induced in healthy subjects after 3 months of high-dose cholecalciferol versus placebo treatment using the same protocol as the D-Lay MS (NCT01817166) study.
- Conditions
- Vitamin d Deficiency
- Being tested
- Vitamin D, Placebo
- Keywords
- Multiple sclerosis, Immunomodulation, lymphocyte subset
- Medical subject headings
- Vitamin D Deficiency, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
100,000 UI
PlaceboDrug
The placebo is identical in appearance to the active treatment: a drinkable solution in ampoules that is clear, yellowish in color with a slightly lemony odor and an oily, slightly sweet, lemony taste.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Not described Receives: Drug: Vitamin D |
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD3+/CD4+
Measured: Month 3
Change in T helper1 (Th1) Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+ /CCR6-
Measured: Month 3
Change in Th1*Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+/CCR+
Measured: Month 3
Change in naive Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7+
Measured: Month 3
Change in effector memory Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7-
Measured: Month 3
Change in central memory Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7+
Measured: Month 3
Change in Teffector memory RA+ Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7-
Measured: Month 3
Change in FOXP3 Treg / Treg Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD25+/CD127+/FOXP3+
Measured: Month 3
Change in naive Treg Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/FOXP3+
Measured: Month 3
Change in memory Treg Lymphocyte T CD4+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/FOXP3+
Measured: Month 3
Change in Tr1 Lymphocyte T cells CD4+ since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD49b+/LAG3+
Measured: Month 3
Change in Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD3+/CD4-
Measured: Month 3
Change in naive Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7+
Measured: Month 3
Change in effector memory Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7-
Measured: Month 3
Change in central memory Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7+
Measured: Month 3
Change in Teffector memory RA+ Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7-
Measured: Month 3
Change in Tc1 Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+/CCR6-
Measured: Month 3
Change in Tc1* Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+/CCR6+
Measured: Month 3
Change in Tc2 Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3-/CCR6-
Measured: Month 3
Change in Tc17 Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3-/CCR6+
Measured: Month 3
Change in CD8 Tcreg / TcReg Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD25+/CD127+/FOXP3+
Measured: Month 3
Change in naive Tcreg Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/FOXP3+
Measured: Month 3
Change in memory Tcreg Lymphocyte T CD8+ cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/FOXP3+
Measured: Month 3
Change in Lymphocyte B cells since baseline
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD19+
Measured: Month 3
Secondary outcomes (21)
lymphocyte subpopulations change in CD6 phenotype after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
lymphocyte subpopulations change in CD162 phenotype after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
lymphocyte subpopulations change in CD226 phenotype after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
lymphocyte subpopulations change in CD46 phenotype after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
lymphocyte subpopulations change in CD11a phenotype after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
lymphocyte subpopulations change in CD49d phenotype after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
lymphocyte subpopulations change in CLA phenotype after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
Change in production of cytokine IL-10 in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
Change in production of cytokine IFNg in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
Change in production of cytokine IL-17 in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo
Measured by Fluorescence Activated Cell Sorting of cells
Measured: Month 3
Change in plasma Vitamin D levels 3 months after baseline of high dose Vitamin D treatment versus placebo
Determination of 25-OH-D2 and 25-OH-D3 forms in nmol/L in plasma with the "vitamin D total II" kit
Measured: Month 3
Change in 16sRNA levels 3 months after baseline of high dose Vitamin D treatment versus placebo
Measured: Month 3
Nature of gut microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Number of operational taxonomic units
Measured: Month 3
Nature of blood microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Number of operational taxonomic units
Measured: Month 3
Percentage of gut microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Percentage of operational taxonomic units
Measured: Month 3
Percentage of blood microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Percentage of operational taxonomic units
Measured: Month 3
Diversity of gut microbiota 3 months after high dose Vitamin D treatment versus placebo
Shannon index
Measured: Month 3
Diversity of blood microbiota 3 months after high dose Vitamin D treatment versus placebo
Shannon index
Measured: Month 3
Beta diversity of gut microbiota 3 months after high dose Vitamin D treatment versus placebo
Bray-Curtis index
Measured: Month 3
Beta diversity of blood microbiota 3 months after high dose Vitamin D treatment versus placebo
Bray-Curtis index
Measured: Month 3
Describing the genetic determinants of vitamin D response using a Single Nucleotide Polymorphism (SNP) database
Description of individual SNPs
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start13 Apr 2023
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Thouvenot, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654818
- Sponsor's protocol ID
- CIVI/2021/ET-01
- Other IDs
- 2022-002157-25
- Acronym
- VDSS
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects: Randomized, Single-center, Double-blind Trial
- ClinicalTrials.gov ID
- NCT05654818
- Acronym / sponsor ID
- VDSS / CIVI/2021/ET-01
- Conditions
- Vitamin d Deficiency
- Keywords
- Multiple sclerosis, Immunomodulation, lymphocyte subset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 16 Dec 2022 (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.
Vitamin D deficiency is associated with the risk of developing MS. Vitamin D treatment has therefore been tested as a background treatment for this pathology, with a seemingly modest clinical effect. Indeed, the first therapeutic trials using high doses of vitamin D (SOLAR and CHOLINE) did not show a significant effect on short-term relapses. However, these two studies showed a significant decrease in the radiological activity of MS on MRI, suggesting a significant immunomodulatory efficacy but a weak clinical benefit in the short term.
Vitamin D has a pleiotropic effect on the immune system inducing overall immunomodulation through transcriptomic modulations, under the control of many individual genetic factors. However, in vivo, only one therapeutic trial has compared the immunological effect of Vitamin D in healthy subjects and in patients with a first demyelinating episode. Analysis of PBMC by flow cytometric cell sorting based on a very small number of markers (CD3, CD8, IL-17, IFN-g) did not find any significant quantitative modulation of Th17 or of their production of IL-10, IL-17 and IFN-g after treatment with Vitamin D measured by ELISA. However, the evolution of anti-inflammatory lymphocyte populations has not been evaluated. A few in vitro studies suggest that the effect of vitamin D may be incomplete on the lymphocytes of MS patients.
The study investigators will use an immunological FACS approach to describe activation markers and measure the intensity of changes induced in healthy subjects after 3 months of high-dose cholecalciferol versus placebo treatment using the same protocol as the D-Lay MS (NCT01817166) study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D |
| Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Women of childbearing potential must have effective contraception during the study period. Effective contraception is defined by a low failure rate (less than 1% per year) when used correctly and consistently, such as implants, injectables, oral contraceptives, IUDs, abstinence, or partner vasectomy. A urine pregnancy test will be performed at inclusion.
Key exclusion criteria (16 listed)
- The subject is participating in another therapeutic study, or is in a period of exclusion determined by a previous study
- The subject is unable to express their consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Pregnant or breastfeeding
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 D100,000 UI | Drug | Vitamin D |
| PlaceboThe placebo is identical in appearance to the active treatment: a drinkable solution in ampoules that is clear, yellowish in color with a slightly lemony odor and an oily, slightly sweet, lemony taste. | Drug | Control |
Primary outcome
Change in Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD3+/CD4+
Change in T helper1 (Th1) Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+ /CCR6-
Change in Th1*Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+/CCR+
Change in naive Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7+
Change in effector memory Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7-
Change in central memory Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7+
Change in Teffector memory RA+ Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7-
Change in FOXP3 Treg / Treg Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD25+/CD127+/FOXP3+
Change in naive Treg Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/FOXP3+
Change in memory Treg Lymphocyte T CD4+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/FOXP3+
Change in Tr1 Lymphocyte T cells CD4+ since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD49b+/LAG3+
Change in Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD3+/CD4-
Change in naive Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7+
Change in effector memory Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7-
Change in central memory Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/CCR7+
Change in Teffector memory RA+ Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/CCR7-
Change in Tc1 Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+/CCR6-
Change in Tc1* Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3+/CCR6+
Change in Tc2 Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3-/CCR6-
Change in Tc17 Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CXCR3-/CCR6+
Change in CD8 Tcreg / TcReg Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD25+/CD127+/FOXP3+
Change in naive Tcreg Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA+/FOXP3+
Change in memory Tcreg Lymphocyte T CD8+ cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD45RA-/FOXP3+
Change in Lymphocyte B cells since baseline
Time frame: Month 3
Percentage variation measured by Fluorescence Activated Cell Sorting of cells CD19+
21 secondary outcomes
lymphocyte subpopulations change in CD6 phenotype after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
lymphocyte subpopulations change in CD162 phenotype after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
lymphocyte subpopulations change in CD226 phenotype after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
lymphocyte subpopulations change in CD46 phenotype after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
lymphocyte subpopulations change in CD11a phenotype after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
lymphocyte subpopulations change in CD49d phenotype after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
lymphocyte subpopulations change in CLA phenotype after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
Change in production of cytokine IL-10 in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
Change in production of cytokine IFNg in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
Change in production of cytokine IL-17 in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo
Time frame: Month 3
Change in plasma Vitamin D levels 3 months after baseline of high dose Vitamin D treatment versus placebo
Time frame: Month 3
Change in 16sRNA levels 3 months after baseline of high dose Vitamin D treatment versus placebo
Time frame: Month 3
Nature of gut microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Nature of blood microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Percentage of gut microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Percentage of blood microbiota taxonomy 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Diversity of gut microbiota 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Diversity of blood microbiota 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Beta diversity of gut microbiota 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Beta diversity of blood microbiota 3 months after high dose Vitamin D treatment versus placebo
Time frame: Month 3
Describing the genetic determinants of vitamin D response using a Single Nucleotide Polymorphism (SNP) database
Time frame: Month 3
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 10 Dec 2025.
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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.
Eric Thouvenot principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin d Deficiency, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 inclusion and 16 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in Lymphocyte T CD4+ cells since baseline (time frame: Month 3). The study lists 24 primary outcomes in all. 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 10 Dec 2025.