Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects
Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Dec 8, 2022
Trial Information
Current as of January 22, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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
Eric Thouvenot
Principal Investigator
CHU de Nimes
About Centre Hospitalier Universitaire De Nīmes
The Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) is a leading academic medical center located in Nîmes, France, dedicated to advancing healthcare through innovative clinical research and patient care. As a prominent sponsor of clinical trials, CHU Nîmes collaborates with a multidisciplinary team of healthcare professionals and researchers to conduct rigorous studies aimed at improving treatment outcomes and enhancing medical knowledge across various specialties. With a strong commitment to ethical standards and patient safety, CHU Nîmes fosters a research environment that encourages scientific excellence and contributes to the development of new therapies and healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nîmes, , France
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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