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

NCT01102374 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 09-0899IND 106541K23AG040708
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Acute Respiratory Infections (ARIs)

  ARIs defined as upper or lower respiratory infections

  12 months

Secondary Outcomes (14)

• Severity of Acute Respiratory Infections

  12 month

• Time to First ARI

  12 months

• Change in 25-hydroxyvitamin D (25OHD) Level

  Baseline and 12 months

• Change in Parathyroid Hormone Level

  Baseline and 12 months

• Falls

  12 months

Study Arms (2)

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.

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.

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

Interventions

High Dose Vitamin D DRUG

Vitamin D3 100,000 IU monthly

High Dose Vitamin D

Standard Dose Vitamin D DRUG

Vitamin D 12,000 IU monthly

Standard Dose Vitamin D

Placebo DRUG

Placebo monthly

Standard Dose Vitamin D

Usual Care DIETARY_SUPPLEMENT

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

High Dose Vitamin D; Standard Dose Vitamin D

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60+ years
• Resides in nursing home

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator
• The American Geriatrics Society: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 27861708 RESULT

MeSH Terms

Conditions

Respiratory Tract Infections; Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Adit Ginde, MD, MPH, Professor of Emergency Medicine
• Organization: University of Colorado School of Medicine

adit.ginde@ucdenver.edu

720-848-6777

Study Officials

• Adit A Ginde, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2010
• First Posted: April 13, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: July 1, 2016
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)