Impact of Vitamin D Supplementation on Immune Functions: Study in Subjects Aged Over 65 Years Vaccinated Against Influenza
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- levels of cathelicidin
Study Overview
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 often deficient in this vitamin may have a double interest:
- By induction of cathelicidin, assist in anti-infective response in particular to the influenza virus
- The normalization of vitamin D status, promote the return to an appropriate immune response limiting excess inflammation and improving capacity to respond.
The entire project will collect new information on the merits of the use of vitamin D in aging. A better knowledge of mechanisms involved and the impact of aging on them is a necessary prerequisite the definition of a new strategy using this drug in the elderly particularly fragile in order to improve its autonomy. This definition seems a sociological interest obvious economic knowing the current aging population and its impact future of our health system.
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,
- Collection of anthropometric data measured size and not declarative weight form examination, measurement of current weight, BMI, waist circumference measurement.
- Food Survey.
- Fasting blood sampling: for dosing of vitamin D, cathelicidin, exploration of immunocompetent cells, calcium, phosphorus, urea and creatinine.
Visit 2: randomization (CPC / CIC-Inserm CIC501)
- Fasting blood sampling: for dosing of vitamin D, cathelicidin, and the serum calcium, phosphorus, urea and creatinine.
- Exploration of immune cells in patients deficient in vitamin D (molecular and cellular analyzes).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- 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 Criteria
- •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 ...).
Arms & Interventions
INTANZA 15
The entire project will collect new information on the merits of the use of vitamin D in aging. A better knowledge of mechanisms involved and the impact of aging on them is a necessary prerequisite the definition of a new strategy using this drug in the elderly particularly fragile in order to improve its autonomy. This definition seems a sociological interest obvious economic knowing the current aging population and its impact future of our health system
Intervention: Vitamin D (drug) (Drug)
vitamin D
The entire project will collect new information on the merits of the use of vitamin D in aging. A better knowledge of mechanisms involved and the impact of aging on them is a necessary prerequisite the definition of a new strategy using this drug in the elderly particularly fragile in order to improve its autonomy. This definition seems a sociological interest obvious economic knowing the current aging population and its impact future of our health system
Intervention: Vitamin D (drug) (Drug)
Outcomes
Primary Outcomes
levels of cathelicidin
Time Frame: at Month 3
Secondary Outcomes
- Levels of plasma 25(OH) D(Day 0, week 7 and Month 3.)
- Rate of seroconversion, seroprotection, the MGT antibodies(Day 0, week 7 and Month 3.)
- Levels of pro-inflammatory cytokines and anti-inflammatory (IL-4, IL-5, IL-10, IL-13, IL-17, IL-23, TFN, IFN and TGF)(Day 0, week 7 and Month 3.)