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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01102374
Enrollment
107
Registered
2010-04-13
Start date
2010-05-31
Completion date
2016-07-31
Last updated
2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infection

Keywords

Vitamin D Deficiency, Respiratory Infection, Nursing Home Residents, Geriatrics, Immunosenescence, Prevention

Brief 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 vitamin D supplementation.

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.

Interventions

DRUGHigh Dose Vitamin D

Vitamin D3 100,000 IU monthly

DRUGStandard Dose Vitamin D

Vitamin D 12,000 IU monthly

DRUGPlacebo

Placebo monthly

DIETARY_SUPPLEMENTUsual Care

Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
The American Geriatrics Society
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 60+ years * Resides in nursing home

Exclusion criteria

* 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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Acute Respiratory Infections (ARIs)12 monthsARIs defined as upper or lower respiratory infections

Secondary

MeasureTime frameDescription
Time to First ARI12 months—
Change in 25-hydroxyvitamin D (25OHD) LevelBaseline and 12 months—
Change in Parathyroid Hormone LevelBaseline and 12 months—
Falls12 months—
Fractures12 months—
Number of Upper Respiratory Infections12 months—
Severity of Acute Respiratory Infections12 monthARIs resulting in emergency department visits or hospitalizations
Number of Influenza-like Illnesses12 months—
Incident Kidney Stones12 months—
Incident Hypercalcemia12 months—
Death12 months—
Number of Urinary Tract Infections12 months—
Number of Other Infections12 months—
Number of Lower Respiratory Infections12 months—

Countries

United States

Participant flow

Participants by arm

ArmCount
High Dose Vitamin D
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. High Dose Vitamin D: Vitamin D3 100,000 IU monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
55
Standard Dose Vitamin D
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. Standard Dose Vitamin D: Vitamin D 12,000 IU monthly Placebo: Placebo monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
52
Total107

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath913
Overall StudyLost to Follow-up76

Baseline characteristics

CharacteristicTotalStandard Dose Vitamin DHigh Dose Vitamin D
25-hydroxyvitamin D level23.0 ng/ml
STANDARD_DEVIATION 9.1
23.0 ng/ml
STANDARD_DEVIATION 9.9
23.0 ng/ml
STANDARD_DEVIATION 8.4
Age, Continuous81 years
STANDARD_DEVIATION 10
82 years
STANDARD_DEVIATION 10
80 years
STANDARD_DEVIATION 10
Region of Enrollment
United States
107 participants52 participants55 participants
Sex: Female, Male
Female
62 Participants29 Participants33 Participants
Sex: Female, Male
Male
45 Participants23 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
53 / 5549 / 52
serious
Total, serious adverse events
9 / 5513 / 52

Outcome results

Primary

Number of Acute Respiratory Infections (ARIs)

ARIs defined as upper or lower respiratory infections

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DNumber of Acute Respiratory Infections (ARIs)32 events
Standard Dose Vitamin DNumber of Acute Respiratory Infections (ARIs)48 events
Secondary

Change in 25-hydroxyvitamin D (25OHD) Level

Time frame: Baseline and 12 months

ArmMeasureValue (MEAN)Dispersion
High Dose Vitamin DChange in 25-hydroxyvitamin D (25OHD) Level8.18 ng/mLStandard Error 0.75
Standard Dose Vitamin DChange in 25-hydroxyvitamin D (25OHD) Level2.71 ng/mLStandard Error 0.8
Secondary

Change in Parathyroid Hormone Level

Time frame: Baseline and 12 months

Population: Issue relating to sample collection/processing precluded measurement of PTH level in the trial

Secondary

Death

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Dose Vitamin DDeath9 Participants
Standard Dose Vitamin DDeath13 Participants
Secondary

Falls

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DFalls70 Events
Standard Dose Vitamin DFalls27 Events
Secondary

Fractures

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DFractures5 events
Standard Dose Vitamin DFractures8 events
Secondary

Incident Hypercalcemia

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Dose Vitamin DIncident Hypercalcemia0 Participants
Standard Dose Vitamin DIncident Hypercalcemia0 Participants
Secondary

Incident Kidney Stones

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Dose Vitamin DIncident Kidney Stones0 Participants
Standard Dose Vitamin DIncident Kidney Stones0 Participants
Secondary

Number of Influenza-like Illnesses

Time frame: 12 months

Population: collected together with lower respiratory infections (not as a separate category)

Secondary

Number of Lower Respiratory Infections

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DNumber of Lower Respiratory Infections11 events
Standard Dose Vitamin DNumber of Lower Respiratory Infections12 events
Secondary

Number of Other Infections

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DNumber of Other Infections33 events
Standard Dose Vitamin DNumber of Other Infections43 events
Secondary

Number of Upper Respiratory Infections

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DNumber of Upper Respiratory Infections21 events
Standard Dose Vitamin DNumber of Upper Respiratory Infections36 events
Secondary

Number of Urinary Tract Infections

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DNumber of Urinary Tract Infections38 events
Standard Dose Vitamin DNumber of Urinary Tract Infections22 events
Secondary

Severity of Acute Respiratory Infections

ARIs resulting in emergency department visits or hospitalizations

Time frame: 12 month

ArmMeasureValue (NUMBER)
High Dose Vitamin DSeverity of Acute Respiratory Infections3 events
Standard Dose Vitamin DSeverity of Acute Respiratory Infections6 events
Secondary

Time to First ARI

Time frame: 12 months

ArmMeasureValue (NUMBER)
High Dose Vitamin DTime to First ARI0.59 Hazard Ratio
Standard Dose Vitamin DTime to First ARI1.00 Hazard Ratio

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026