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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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

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Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

High Dose Vitamin D

Intervention Type DRUG

Vitamin D3 100,000 IU monthly

Usual Care

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

Standard Dose Vitamin D

Intervention Type DRUG

Vitamin D 12,000 IU monthly

Placebo

Intervention Type DRUG

Placebo monthly

Usual Care

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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High Dose Vitamin D

Vitamin D3 100,000 IU monthly

Intervention Type DRUG

Standard Dose Vitamin D

Vitamin D 12,000 IU monthly

Intervention Type DRUG

Placebo

Placebo monthly

Intervention Type DRUG

Usual Care

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No