The study population consisted of healthy subjects (women and men) recruited at the University Hospital of Nîmes in order to be comparable in age (± 5 years) and sex (frequency matching) to patients included in a study carried out at the University Hospital of Nîmes with a similar design but involving patients with multiple sclerosis (VITADIMS cohort included in the original D-Lay MS study) MedDRA version: 21.0 Level: LLT Classification code 10028247 Term: Multiple sclerosis like syndrome Syste
Conditions
Interventions
Trade Name: UVEDOSE 2.5mg (100 000 UI)
Product Name: UVEDOSE
Pharmaceutical Form: Oral solution in single-dose container
Pharmaceutical form of the placebo: Oral solution in single-dose container
Rout
Sponsors
CHU de Nîmes
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy subject at least = 18 years of age and less than = 65 years of age. - Healthy subject must have given free and informed consent and signed the consent. - The healthy subject must be a member or beneficiary of a health insurance plan. - Women of childbearing potential must have effective contraception for the duration of the study. Effective contraception is defined as 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - minor subject - Infectious disease or vaccination less than 3 months old. - 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 - Present or past neurological symptoms that may suggest an undiagnosed inflammatory neurological pathology. - Active vitamin supplementation or intake of vitamin D-rich food supplements. - Subject is participating in another therapeutic study. - subject unable to express his consent - The subject is in an exclusion period determined by a previous study. - Subject is under court protection, guardianship, or conservatorship. - Subject refuses to sign consent. - Subject cannot be given informed information (unable to understand the study, language problem).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe and compare the evolution of circulating lymphocyte populations (Treg, Teff, Th1, Th17, Tr1, LB) in healthy subjects before and after 3 months of high dose vitamin D treatment or before and after 3 months of placebo;Secondary Objective: A- Compare the evolution of the activation state and the expression of adhesion molecules of different circulating lymphocyte populations (Treg, Teff, Th1, Th17, Tr1, LB) before and after 3 months of high dose vitamin D treatment versus before and after 3 months of placebo in healthy subjects. B- Compare the evolution of plasma Vitamin D levels before and after 3 months of high dose Vitamin D treatment versus before and after 3 months of placebo in healthy subjects C- Describe and compare the taxonomic characteristics and the metabolism of the intestinal microbiota after 3 months of high dose vitamin D treatment or after 3 months of placebo in healthy subjects D- To build a biobank (plasma, serum, PBMC, stool) from the samples collected. ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Day 0 and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A- For each population (Treg, Teff, Th1, Th17, Tr1, LB) analyzed by FACS, quantification of the expression of activation and adhesion molecules and of pro- and anti-inflammatory cytokines (IL-10, IFNg and IL-17) B- Plasma level of Vitamin D. C- Nature and relative quantification of bacterial proteins and OTUs (bacterial taxonomic units) present in stool samples, identified by metagenomics and metabolomics. ;Timepoint(s) of evaluation of this end point: T0 et 3 months 3 months only for faeces | — |
Countries
France
Contacts
Public ContactBrigitte LAFONT
CHU de Nîmes
Outcome results
None listed