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Could a vitamin d boost make flu shots work better for seniors?

NCT ID NCT01893385

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Jun 2013

Finished

Nov 2014

Lead sponsor

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

65 to 85 years

Sex

Anyone

Healthy volunteers

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

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

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France