D Vitamin Deficiency PatientsPhase 2NCT01893385
Vitamin D Supplementation and the Immune Response
A Phase 2 study testing Vitamin D (drug) in people with D Vitamin Deficiency Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- D Vitamin Deficiency Patients
- What is being tested?
- Vitamin D (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 ...).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Vitamin D Supplementation on Immune Functions: Study in Subjects Aged Over 65 Years Vaccinated Against Influenza
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:
Read more
- 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.
Read the 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).
Start of vitamin D supplementation or placebo
- Subjects with vitamin D levels <30ng/mL will be randomized into two groups:
- Arm receiving vitamin D (BS).
- Arm receiving placebo (BC).
- 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)
- Fasting blood assay for vitamin D and calcium collection.
- urinary dosage calcium. Visit 4: Month 2 (CPC / CIC-Inserm CIC501)
- Validation of laboratory measurements made by an independent medical M2 protocol.
- Delivery of products to test for the third month of vitamin supplementation / placebo.
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:
- If [25(OH) D]> 75 ng / ml and / or calcium levels> 106 mg / ml and / or calcium excretion> 300 mg / l: presentation of two bulbs placebo.
- If [25(OH) D] <75 ng / ml and serum calcium <106 mg / ml and calcium excretion <300 mg / l: presentation of two ampoules of Vitamin D. Visit 5 - Month 3 vaccination INTANZA 15 ® (3 months after the start of supplementation)
- Recovery of boxes and empty ampoules of vitamin D.
- Evaluation of the clinical safety of vitamin D.
- Collection of anthropometric data: measurement of current weight and BMI,
- Fasting blood sampling: for dosing of vitamin D, cathelicidin, exploration of immunocompetent cells, calcium, phosphorus, urea and creatinine.
- Influenza serology, Visit 6 - Month 4: end of study
- Clinical examination with assessment of tolerability of vaccination and delivery of the form of reporting due to immunization and infectious complications side effects according to the criteria of toxicity CTCNCI Bethesda,
- Collection of anthropometric data: measurement of current weight, calculating the weight change,
- Fasting blood sampling: for dosing of vitamin D, cathelicidin, exploration of immunocompetent cells, calcium, phosphorus, urea and creatinine.
- Measurement of seroconversion, seroprotection, MGT antibodies following vaccination.
End of the study Removal of anonymity for physician investigators to propose a vitamin D the subjects who received placebo.
- Conditions
- D Vitamin Deficiency Patients
- Being tested
- Vitamin D (drug)
- Keywords
- vitamin D, supplementation, immunocompetente cells, immune system, influenza vaccine, elderly
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (drug)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vitamin D (drug) |
| 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 Receives: Drug: Vitamin D (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of cathelicidin
Measured: at Month 3
Secondary outcomes (3)
Levels of plasma 25(OH) D
Measured: 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)
Measured: Day 0, week 7 and Month 3.
Rate of seroconversion, seroprotection, the MGT antibodies
Measured: Day 0, week 7 and Month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for D Vitamin Deficiency PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri LAURICHESSE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893385
- Sponsor's protocol ID
- CHU-0160
- Other IDs
- 2012-005658-52
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2013
- Last updated
- 6 Aug 2026
- Results posted
- No
Publications
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.
PubMed 30800121
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Supplementation on Immune Functions: Study in Subjects Aged Over 65 Years Vaccinated Against Influenza
- ClinicalTrials.gov ID
- NCT01893385
- Acronym / sponsor ID
- CHU-0160
- Conditions
- D Vitamin Deficiency Patients
- Keywords
- vitamin D, supplementation, immunocompetente cells, immune system, influenza vaccine, elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Start of vitamin D supplementation or placebo
- Subjects with vitamin D levels <30ng/mL will be randomized into two groups:
- Arm receiving vitamin D (BS).
- Arm receiving placebo (BC).
- 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)
- Fasting blood assay for vitamin D and calcium collection.
- urinary dosage calcium. Visit 4: Month 2 (CPC / CIC-Inserm CIC501)
- Validation of laboratory measurements made by an independent medical M2 protocol.
- Delivery of products to test for the third month of vitamin supplementation / placebo.
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:
- If [25(OH) D]> 75 ng / ml and / or calcium levels> 106 mg / ml and / or calcium excretion> 300 mg / l: presentation of two bulbs placebo.
- If [25(OH) D] <75 ng / ml and serum calcium <106 mg / ml and calcium excretion <300 mg / l: presentation of two ampoules of Vitamin D. Visit 5 - Month 3 vaccination INTANZA 15 ® (3 months after the start of supplementation)
- Recovery of boxes and empty ampoules of vitamin D.
- Evaluation of the clinical safety of vitamin D.
- Collection of anthropometric data: measurement of current weight and BMI,
- Fasting blood sampling: for dosing of vitamin D, cathelicidin, exploration of immunocompetent cells, calcium, phosphorus, urea and creatinine.
- Influenza serology, Visit 6 - Month 4: end of study
- Clinical examination with assessment of tolerability of vaccination and delivery of the form of reporting due to immunization and infectious complications side effects according to the criteria of toxicity CTCNCI Bethesda,
- Collection of anthropometric data: measurement of current weight, calculating the weight change,
- Fasting blood sampling: for dosing of vitamin D, cathelicidin, exploration of immunocompetent cells, calcium, phosphorus, urea and creatinine.
- Measurement of seroconversion, seroprotection, MGT antibodies following vaccination.
End of the study Removal of anonymity for physician investigators to propose a vitamin D the subjects who received placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Experimental | Drug: Vitamin D (drug)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 | Drug: Vitamin D (drug)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 |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D (drug) | Drug | INTANZA 15, vitamin D |
Primary outcome
levels of cathelicidin
Time frame: at Month 3
3 secondary outcomes
Levels of plasma 25(OH) D
Time frame: 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)
Time frame: Day 0, week 7 and Month 3.
Rate of seroconversion, seroprotection, the MGT antibodies
Time frame: Day 0, week 7 and Month 3.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 30800121Goncalves-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henri LAURICHESSE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D (drug) in people with D Vitamin Deficiency Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of cathelicidin (time frame: at Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.