Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT05654818
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05654818
Study Brief:
Protocol Section:
NCT05654818