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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005658-52 |
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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:
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.
CONDUCT OF THE STUDY:
Visit 1: selection of subjects (CPC / CIC-Inserm CIC501)
Visit 2: randomization (CPC / CIC-Inserm CIC501)
Start of vitamin D supplementation or placebo
Subjects with vitamin D levels <30ng/mL will be randomized into two groups:
It will be given to the patient 4 bulbs product (vitamin D or placebo) for supplementation for 2 months (1 / 15 days).
Call subjects at 4 weeks of vitamin supplementation / placebo to assess the clinical safety of the product, as well as compliance with the instructions of supplementation.
Visit 3: After seven weeks of vitamin supplementation / placebo (CPC / CIC-Inserm CIC501)
For the placebo group given two bulbs for the third month placebo placebo supplementation.
For the VitD group: dose adjustment according to the following scheme:
End of the study Removal of anonymity for physician investigators to propose a vitamin D the subjects who received placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D | Experimental | 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 |
|
| INTANZA 15 | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (drug) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| levels of cathelicidin | at Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of plasma 25(OH) D | 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. |
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Inclusion Criteria:
- Aged 65 or over subject,
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri LAURICHESSE | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30800121 | Derived | Goncalves-Mendes N, Talvas J, Duale C, Guttmann A, Corbin V, Marceau G, Sapin V, Brachet P, Evrard B, Laurichesse H, Vasson MP. Impact of Vitamin D Supplementation on Influenza Vaccine Response and Immune Functions in Deficient Elderly Persons: A Randomized Placebo-Controlled Trial. Front Immunol. 2019 Feb 8;10:65. doi: 10.3389/fimmu.2019.00065. eCollection 2019. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Rate of seroconversion, seroprotection, the MGT antibodies | Day 0, week 7 and Month 3. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |