Respiratory InfectionPhase 2NCT01102374

Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents

A Phase 2 study testing High Dose Vitamin D and Standard Dose Vitamin D in people with Respiratory Infection, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose… Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Respiratory Infection
What is being tested?: High Dose Vitamin D and Standard Dose Vitamin D
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 1 siteUnited States
Study dates: May 2010to Jul 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 60+ years
Resides in nursing home

Who cannot join

Terminal illness (expected survival <6 months)
Anticipated discharge within 12 months
Unable to take whole or crushed tablets
Active cancer, except squamous/basal cell carcinoma
Severe malnutrition (body mass index <18 kg/m2)
Current immunosuppressive medications (including corticosteroids)

Show all 14Show fewer

Renal failure (estimated glomerular filtration rate < 15 mL/min/1.73m2)
Currently taking >1,000 IU/d vitamin D supplementation
History (or strong family history) of kidney stones
History of sarcoidosis or other granulomatous disorders associated with hypercalcemia
Elevated baseline hypercalcemia (albumin-adjusted serum calcium >10.5 mg/dL)
Baseline serum 25OHD level ≥ 100 nmol/L
Inability to provide informed consent and no available healthcare legally authorized representative
Inability of participant or legally authorized representative to speak/understand English

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver
Aurora, Colorado, 80045

Other trials in United States

About this study

Read the detailed description

This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.

Conditions: Respiratory Infection
Being tested: High Dose Vitamin D, Standard Dose Vitamin D, Placebo, Usual Care
Keywords: Vitamin D Deficiency, Respiratory Infection, Nursing Home Residents, Geriatrics, Immunosenescence, Prevention
Medical subject headings: Respiratory Tract Infections, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Dose Vitamin DDrug
Vitamin D3 100,000 IU monthly
Standard Dose Vitamin DDrug
Vitamin D 12,000 IU monthly
PlaceboDrug
Placebo monthly
Usual CareDietary supplement
Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Study groups in NCT01102374
Study group	Role	What they receive
High Dose Vitamin D	Experimental	100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day. Receives: Drug: High Dose Vitamin D; Dietary Supplement: Usual Care
Standard Dose Vitamin D	Active comparator	12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day. Receives: Drug: Standard Dose Vitamin D; Drug: Placebo; Dietary Supplement: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Acute Respiratory Infections (ARIs)
ARIs defined as upper or lower respiratory infections
Measured: 12 months

Secondary outcomes (14)

Severity of Acute Respiratory Infections
ARIs resulting in emergency department visits or hospitalizations
Measured: 12 month
Time to First ARI
Measured: 12 months
Change in 25-hydroxyvitamin D (25OHD) Level
Measured: Baseline and 12 months
Change in Parathyroid Hormone Level
Measured: Baseline and 12 months
Falls
Measured: 12 months
Fractures
Measured: 12 months
Number of Upper Respiratory Infections
Measured: 12 months
Number of Lower Respiratory Infections
Measured: 12 months
Number of Influenza-like Illnesses
Measured: 12 months
Incident Kidney Stones
Measured: 12 months
Incident Hypercalcemia
Measured: 12 months
Death
Measured: 12 months
Number of Urinary Tract Infections
Measured: 12 months
Number of Other Infections
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jul 2016

First posted13 Apr 2010 (estimated)
Study startMay 2010
Primary completionAug 2014
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory InfectionStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01102374
Sponsor's protocol ID: 09-0899
Other IDs: IND 106541, K23AG040708
Status last verified: Apr 2017
First submitted: 11 Apr 2010
Last updated: 21 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ginde AA, Blatchford P, Breese K, Zarrabi L, Linnebur SA, Wallace JI, Schwartz RS. High-Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long-Term Care Residents: A Randomized Clinical Trial. J Am Geriatr Soc. 2017 Mar;65(3):496-503. doi: 10.1111/jgs.14679. Epub 2016 Nov 16.
PubMed 27861708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
ClinicalTrials.gov ID: NCT01102374
Acronym / sponsor ID: 09-0899
Conditions: Respiratory Infection
Keywords: Vitamin D Deficiency, Respiratory Infection, Nursing Home Residents, Geriatrics, Immunosenescence, Prevention
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), The American Geriatrics Society
Study start: May 2010
Primary completion: Aug 2014 (actual)
Study completion: Jul 2016 (actual)
First posted: 13 Apr 2010 (estimated)
Results: Posted 21 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
High Dose Vitamin D	Experimental	Drug: High Dose Vitamin D, Dietary Supplement: Usual Care100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
Standard Dose Vitamin D	Active comparator	Drug: Standard Dose Vitamin D, Drug: Placebo, Dietary Supplement: Usual Care12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age 60+ years
Resides in nursing home

Key exclusion criteria (14 listed)

Terminal illness (expected survival <6 months)
Anticipated discharge within 12 months
Unable to take whole or crushed tablets
Active cancer, except squamous/basal cell carcinoma
Severe malnutrition (body mass index <18 kg/m2)

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
High Dose Vitamin DVitamin D3 100,000 IU monthly	Drug	High Dose Vitamin D
Standard Dose Vitamin DVitamin D 12,000 IU monthly	Drug	Standard Dose Vitamin D
PlaceboPlacebo monthly	Drug	Standard Dose Vitamin D
Usual CareUsual care of 0-1000 IU vitamin D daily. This is present in both study arms.	Dietary supplement	High Dose Vitamin D, Standard Dose Vitamin D

Primary outcome

Number of Acute Respiratory Infections (ARIs)
Time frame: 12 months
ARIs defined as upper or lower respiratory infections

14 secondary outcomes

Severity of Acute Respiratory Infections
Time frame: 12 month
Time to First ARI
Time frame: 12 months
Change in 25-hydroxyvitamin D (25OHD) Level
Time frame: Baseline and 12 months
Change in Parathyroid Hormone Level
Time frame: Baseline and 12 months
Falls
Time frame: 12 months
Fractures
Time frame: 12 months
Number of Upper Respiratory Infections
Time frame: 12 months
Number of Lower Respiratory Infections
Time frame: 12 months
Number of Influenza-like Illnesses
Time frame: 12 months
Incident Kidney Stones
Time frame: 12 months
Incident Hypercalcemia
Time frame: 12 months
Death
Time frame: 12 months
Number of Urinary Tract Infections
Time frame: 12 months
Number of Other Infections
Time frame: 12 months

Results and safety

Results posted to the registry on 21 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose Vitamin D	55	39
Standard Dose Vitamin D	52	33

Primary outcome: Number of Acute Respiratory Infections (ARIs)

Time frame: 12 months. Number. Unit: events

Measure	High Dose Vitamin D n = 55	Standard Dose Vitamin D n = 52
Value	32	48

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose Vitamin D	9 of 55 (16.4%)	53 of 55 (96.4%)	Not reported
Standard Dose Vitamin D	13 of 52 (25%)	49 of 52 (94.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27861708Ginde AA, Blatchford P, Breese K, Zarrabi L, Linnebur SA, Wallace JI, Schwartz RS. High-Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long-Term Care Residents: A Randomized Clinical Trial. J Am Geriatr Soc. 2017 Mar;65(3):496-503. doi: 10.1111/jgs.14679. Epub 2016 Nov 16.
Individual participant dataSharing planned: No

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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.

Adit A Ginde, MD, MPH principal investigator

University of Colorado, Denver

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 High Dose Vitamin D and Standard Dose Vitamin D in people with Respiratory Infection, run by University of Colorado, Denver at 1 site in United States.

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 2 inclusion and 14 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: finished, as of the sponsor's last update on 21 Apr 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Acute Respiratory Infections (ARIs) (time frame: 12 months). 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 NCT01102374, 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 21 Apr 2017.