Status:
TERMINATED
Vitamin D Supplementation and the Immune Response
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
D Vitamin Deficiency Patients
Eligibility:
All Genders
65-85 years
Phase:
PHASE2
Brief Summary
The main objective is to assess the variation in plasma levels of cathelicidin before and after influenza vaccination. All bibliographic data suggests that supplementation vitamin D in the elderly of...
Detailed Description
CONDUCT OF THE STUDY: Visit 1: selection of subjects (CPC / CIC-Inserm CIC501) * Medical Examination, clinical examination, explanation of the protocol and collection of written consent, * Collectio...
Eligibility Criteria
Inclusion
- \- Aged 65 or over subject,
- Subjects with a vitamin D levels below 30 ng / ml,
- Acceptance of vitamin D (100 000 IU of UVEDOSE ®)
- Acceptance of influenza vaccination with INTANZA15 ®
- Affiliation to a social security scheme
- The subject agrees not to change their eating habits
Exclusion
- Liver disease: cirrhosis, chronic hepatitis.
- Renal impairment whatever degree
- Hypercalcemia (serum calcium\> 2.6 mol / l)
- Hypo-or hyperparathyroidism history, history of renal colic.
- Disease / acute infection, moderate or severe (at the discretion of the investigator) on the day of vaccination or febrile illness (temperature ≥ 38 ° C). The subject should not be included in the study as his condition is not cured or her fever has not gone down).
- Long-term treatment with bisphosphonates, corticosteroids, anti-inflammatory, anticonvulsant, antiepileptics, fibrates.
- Known hypersensitivity to vitamin D
- Prior supplementation (in the last year) or supplementation of vitamin D during
- Participation at the time of inclusion in the trial, or planned participation during the same period that this trial, another trial on a vaccine, drug, medical device.
- Vaccination during the 4 weeks prior to vaccination or immunization of the test set out in the three weeks after vaccination test.
- Transfusion of immunoglobulins, blood or blood products during the last 3 months
- Congenital or acquired, known or suspected immunodeficiency, immunosuppressive therapy in the last 6 months, such as cancer chemotherapy or radiotherapy; steroids long-term systemic (prednisone or equivalent for more than two consecutive weeks in the Previous 3 months).
- Systemic Hypersensitivity to any component of the vaccine (ovalbumin, chicken protein, neomycin, formaldehyde, octoxinol 9), or a history of reaction to influenza vaccine or a vaccine containing one of the substances in the vaccine trial, which involved life-threatening.
- Deprivation of liberty or by administrative order issued by a court, subject to emergency medical or involuntary hospitalization.
- Topic enjoying a measure of legal protection (guardianship, guardianship ...).
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01893385
Start Date
June 1 2013
End Date
November 1 2014
Last Update
December 23 2015
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003