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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Respiratory Infection

Treatments: Drug: High Dose Vitamin D; Drug: Standard Dose Vitamin D; Drug: Placebo; Dietary Supplement: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01102374

09-0899

K23AG040708 (U.S. NIH Grant/Contract)

IND 106541 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 2 patient groups

High Dose Vitamin D

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Usual Care

Drug: High Dose Vitamin D

Standard Dose Vitamin D

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Usual Care

Drug: Standard Dose Vitamin D

Drug: Placebo