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Vitamin D Supplementation and the Immune Response

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ClinicalTrials.gov Identifier: NCT01893385
Recruitment Status : Terminated
First Posted : July 9, 2013
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
D Vitamin Deficiency Patients Drug: Vitamin D (drug) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Vitamin D Supplementation on Immune Functions: Study in Subjects Aged Over 65 Years Vaccinated Against Influenza
Study Start Date : June 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 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
Drug: Vitamin D (drug)
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
Drug: Vitamin D (drug)



Primary Outcome Measures :
  1. levels of cathelicidin [ Time Frame: at Month 3 ]

Secondary Outcome Measures :
  1. Levels of plasma 25(OH) D [ Time Frame: Day 0, week 7 and Month 3. ]
  2. Levels of pro-inflammatory cytokines and anti-inflammatory (IL-4, IL-5, IL-10, IL-13, IL-17, IL-23, TFN, IFN and TGF) [ Time Frame: Day 0, week 7 and Month 3. ]
  3. Rate of seroconversion, seroprotection, the MGT antibodies [ Time Frame: Day 0, week 7 and Month 3. ]


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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ...).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893385


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Henri LAURICHESSE University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01893385     History of Changes
Other Study ID Numbers: CHU-0160
2012-005658-52
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by University Hospital, Clermont-Ferrand:
vitamin D
supplementation
immunocompetente cells, immune system
influenza vaccine
elderly
Additional relevant MeSH terms:
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Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents