Could a vitamin d boost make flu shots work better for seniors?
NCT ID NCT01893385
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests whether giving older adults a high dose of vitamin D before their flu shot can strengthen their immune response. Participants are 65 or older with low vitamin D levels. The study measures changes in infection-fighting proteins and antibody levels after vaccination, to see if correcting vitamin D deficiency helps the body respond better to the flu vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin D (as a single high-dose supplement, 100,000 IU) given alongside the seasonal influenza vaccine
- What this could lead to
- If vitamin D boosts the immune response to flu vaccination in older adults, it could point toward a simple, low-cost way to strengthen protection against flu and other infections in aging populations.
- What could go wrong
- This is a small, early-stage trial, so results may not apply broadly. Vitamin D may not meaningfully change immune response, and high-dose supplements carry a small risk of side effects like elevated calcium levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
37 people
The number who actually took part.
- Start date
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Jun 2013
- Finished
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Nov 2014
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ...).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France