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Completed

NCT Number: NCT01102374

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

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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Key information

Conditions

Respiratory Infection Avitaminosis Deficiency Diseases Infections Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Respiratory Tract Diseases Respiratory Tract Infections Vitamin D Deficiency

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Dose Vitamin D

Drug

Vitamin D3 100,000 IU monthly

Standard Dose Vitamin D

Drug

Vitamin D 12,000 IU monthly

Placebo

Drug

Placebo monthly

Usual care

Dietary Supplement

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

Primary outcomes

  1. Number of Acute Respiratory Infections (ARIs)

    Time frame: 12 months

    ARIs defined as upper or lower respiratory infections

Secondary outcomes

  1. Severity of Acute Respiratory Infections

    Time frame: 12 month

    ARIs resulting in emergency department visits or hospitalizations

  2. Time to First ARI

    Time frame: 12 months

  3. Change in 25-hydroxyvitamin D (25OHD) Level

    Time frame: Baseline and 12 months

  4. Change in Parathyroid Hormone Level

    Time frame: Baseline and 12 months

  5. Falls

    Time frame: 12 months

  6. Fractures

    Time frame: 12 months

  7. Number of Upper Respiratory Infections

    Time frame: 12 months

  8. Number of Lower Respiratory Infections

    Time frame: 12 months

  9. Number of Influenza-like Illnesses

    Time frame: 12 months

  10. Incident Kidney Stones

    Time frame: 12 months

  11. Incident Hypercalcemia

    Time frame: 12 months

  12. Death

    Time frame: 12 months

  13. Number of Urinary Tract Infections

    Time frame: 12 months

  14. Number of Other Infections

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)
  • The American Geriatrics Society

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Apr 13, 2010
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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