CompletedNot a drug-phase studyMS (type not specified)NCT056548182022-002157-25

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Ergocalciferol

    Vitamin D receptor agonist

  • UVEDOSE

Placebo or sham

  • Placebo

What it measured

Main measures

  • Change in Lymphocyte T CD4+ cells since baseline

    Month 3

    Immune response
  • Change in T helper1 (Th1) Lymphocyte T CD4+ cells since baseline

    Month 3

    Immune response
  • Change in Th1*Lymphocyte T CD4+ cells since baseline

    Month 3

    Immune response
  • Change in naive Lymphocyte T CD4+ cells since baseline

    Month 3

    Immune response
  • Change in effector memory Lymphocyte T CD4+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in central memory Lymphocyte T CD4+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in Teffector memory RA+ Lymphocyte T CD4+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in FOXP3 Treg / Treg Lymphocyte T CD4+ cells since baseline

    Month 3

    Immune response
  • Change in naive Treg Lymphocyte T CD4+ cells since baseline

    Month 3

    Immune response
  • Change in memory Treg Lymphocyte T CD4+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in Tr1 Lymphocyte T cells CD4+ since baseline

    Month 3

    Immune response
  • Change in Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in naive Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in effector memory Lymphocyte T CD8+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in central memory Lymphocyte T CD8+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in Teffector memory RA+ Lymphocyte T CD8+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in Tc1 Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in Tc1* Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in Tc2 Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in Tc17 Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in CD8 Tcreg / TcReg Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in naive Tcreg Lymphocyte T CD8+ cells since baseline

    Month 3

    Immune response
  • Change in memory Tcreg Lymphocyte T CD8+ cells since baseline

    Month 3

    Thinking and memoryImmune response
  • Change in Lymphocyte B cells since baseline

    Month 3

    Immune response
  • Change in the level (%) of each circulating lymphocyte population (Treg, Teff, Th1, Th17, Tr1, LB) before and after 3 months of treatment with high-dose Vitamin D or placebo.

    Immune response

Other measures (22)

  • lymphocyte subpopulations change in CD6 phenotype after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • lymphocyte subpopulations change in CD162 phenotype after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • lymphocyte subpopulations change in CD226 phenotype after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • lymphocyte subpopulations change in CD46 phenotype after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • lymphocyte subpopulations change in CD11a phenotype after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • lymphocyte subpopulations change in CD49d phenotype after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • lymphocyte subpopulations change in CLA phenotype after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • Change in production of cytokine IL-10 in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • Change in production of cytokine IFNg in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response
  • Change in production of cytokine IL-17 in lymphocyte subpopulations after 3 months of high dose vitamin D treatment or placebo

    Month 3

    Immune response

Who could take part

MS (type not specified) · 18 to 65

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Apr 2023

    2. Main results due

      Oct 2023

    3. Finished

      Oct 2023

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