Status:
COMPLETED
Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Aging (NIA)
Merck Sharp & Dohme LLC
Conditions:
Immunosenescence
Shingles
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
This is an ancillary study to a randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374). In this study, a subset of trial subjects will receive the zoster va...
Detailed Description
Objectives 1. To determine the increase in Varicella-zoster virus (VZV)-specific cell-mediated immune response from pre-zoster vaccination to 3 weeks post-vaccination in nursing home residents after ...
Eligibility Criteria
Inclusion
- Aged ≥ 60 years;
- Residing in a long-term care facility;
- Have not yet received VZV vaccine
Exclusion
- 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 (eGFR\<15 mL/min/1.73m2);
- currently taking \>800 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);
- serum 25 (OH)D level ≥40 ngl/ml at baseline;
- inability to provide informed consent and no available healthcare proxy;
- inability of participant or proxy to speak/understand English.
- previous receipt of the Zostavax (anticipate \<10% of trial;
- known allergy to gelatin, neomycin, or any other component of the vaccine.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01262300
Start Date
November 1 2010
End Date
January 23 2014
Last Update
June 25 2021
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045