Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents

Completed · Phase 1

Conditions studied: Immunosenescence, Shingles

In brief

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 vaccine and the investigators will determine the immunological response to the vaccine in this older, frail population, as well as the association between vitamin D and immunological outcomes.

Key facts

Study ID

NCT01262300

Run by

University of Colorado, Denver

People needed

33

Starts

2010-11-01

Expected to finish

2014-01-23

Last updated by the study team

2021-06-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 60 years;
• Residing in a long-term care facility;
• Have not yet received VZV vaccine

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 (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.

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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