Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Dec 8, 2022

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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.

Trial Officials