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Vitamin D in Ventilated ICU Patients (R21 HL-110044)

10. november 2016 oppdatert av: Greg S. Martin, M.D., M.Sc., Emory University

High-Dose Vitamin D and Antimicrobial Peptide Expression in Lung Failure

The increasing rate of hospital-acquired infection and antibiotic resistance are major causes of prolonged ICU stay and death in hospitalized patients. The enormous impact of ICU-related infection demands the need for cost-effective therapies that can be rapidly implemented to improve patient immune response to control infection. Unfortunately, little high-quality comparative effectiveness research has been performed on micronutrient treatment regimens as methods to decrease hospital-acquired infection in critically ill patients. Critically ill medical and surgical patients have an extremely high prevalence of vitamin D insufficiency.

We will perform a rigorous, double-blind, randomized, controlled, pilot clinical trial in ventilator-dependent ICU patients to test the clinical/metabolic safety and efficacy of two doses of oral high-dose vitamin D3 therapy versus standard therapy (no supplemental vitamin D). The primary endpoint is to test whether high-dose regimens [either 50,000 or 100,000 international units (IU) of enteral vitamin D3 given daily for 5 consecutive days (total dose = 250,000 or 500,000 IU, respectively) increase plasma 25(OH)D concentrations into a desirable range (> 30 ng/mL).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  1. We will evaluate, over 12 weeks, the safety and efficacy of two high-dose vitamin D3 regimens in severely ill ICU patients. Vitamin D or placebo ( depending on study arm) will be given sequentially in divided doses for 5 days
  2. We will explore whether these vitamin D regimens are capable of increasing the production of key antimicrobial peptides LL-37 and hBD-2 ( substances produced by our bodies to fight infections), in both the blood and in lung.
  3. We will determine whether a higher vitamin D level in the blood is associated with a decrease in hospital infection rates and other complications in high-risk ICU patients with respiratory failure.

Study Design:

Enrollment goal is 36 patients. Once consent is obtained subjects will be randomly assigned to one of three study groups. Each group consists of 12 patients with enteral access ; a placebo arm, an arm where subjects receive 50,000 IU of Vitamin D for 5 days, and a third arm where subjects receive 100,000 IU of Vitamin D for 5 days.

Methods: Baseline blood samples (25-hydroxyvitamin D, vitamin D binding protein, ionized calcium, LL-37,and hBD-2) will be taken on study day 7,14,21,28,84 days. On study day 1 and 8, LL-37, hBD-2, cathelicidin from BAL fluid will also be analyzed. Patients will be given either placebo, Vitamin D3 50,000 IU x 5 days (total 250,000 IU) or Vitamin D3 100,000 IU x 5 days (total 500,000 IU) with an intention to treat model. Baseline data on the patients including demographic, laboratory, documented infections, severity illness score (APACHE II) and organ dysfunction score (SOFA) will be collected. ELISA assay on the serum and BAL will be performed.

Studietype

Intervensjonell

Registrering (Faktiske)

31

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital
      • Atlanta, Georgia, Forente stater, 30308
        • Emory University Hospital Midtown

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Receiving care in an intensive care unit (ICU)
  • Age greater than 18 years
  • Expected to require mechanical ventilation for at least 72 hours after entry
  • Expected to survive and remain in the ICU for at least 96 hours after study entry
  • To enable delivery of study drug, the subject has enteral access in place and is deemed able to tolerate enteral drug administration

Exclusion Criteria:

  • Inability to obtain or declined informed consent from the subject and/or legally authorized representative
  • Pregnancy
  • Ongoing shock
  • Current hypercalcemia (albumin-corrected serum calcium > 10.8 mg/dL or ionized calcium > 5.2 mg/dL)
  • History of therapy with high-dose vitamin D to treat vitamin D deficiency within previous 6 months
  • History of disorders associated with hypercalcemia; history of cancer with history of hypercalcemia within the past 1 year, hyperparathyroidism, sarcoidosis, nephrolithiasis]
  • Chronic renal dysfunction requiring chronic dialysis
  • Known history of cirrhosis
  • History of AIDS
  • The patient has received any investigational drug within 60 days prior to study entry.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Enteral vitamin D3 50,000 IU
An arm where subjects receive 50,000 IU of Vitamin D for 5 days.
Legemiddel: Enteral Vitamin D3 50,000 IU
Enteral Vitamin D3 50,000IU x 5 days (total dose 250,000IU)
Eksperimentell: Enteral Vitamin D3 100,000 IU
Arm where subjects receive 100,000 IU of Vitamin D for 5 days
Legemiddel: Enteral Vitamin D3 100,000IU
Enteral Vitamin D3 100,000IU over 5 days (total 500,000IU)
Placebo komparator: Inactive Substance
Arm where patients receive inactive substance for 5 days.
Annen: Inactive substance
Inactive substance given enterally for 5 days.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline
Tidsramme: Baseline
The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.
Baseline
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7
Tidsramme: Day 7
The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement.
Day 7
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14
Tidsramme: Day 14
The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement.
Day 14
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21
Tidsramme: Day 21
The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement.
Day 21
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28
Tidsramme: Day 28
The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement.
Day 28
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84
Tidsramme: Day 84
The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement.
Day 84

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Plasma LL-37 Levels
Tidsramme: Baseline, Day 7, Day 14
Plasma LL-37 was measured at Baseline, Day 7 and Day 14.
Baseline, Day 7, Day 14
Duration of Time on Ventilator
Tidsramme: 12 weeks
The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported.
12 weeks
Duration of Time in Intensive Care Unit (ICU)
Tidsramme: 12 weeks
The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported.
12 weeks
Duration of Time in Hospital
Tidsramme: 12 weeks
The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported.
12 weeks
Change in Sequential Organ Failure Assessment (SOFA) Score
Tidsramme: Baseline, Day 7
Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score.
Baseline, Day 7
Number of Hospital Acquired Infections
Tidsramme: 12 weeks
The number of study participants who had a hospital acquired infection.
12 weeks
Number of Hospital Mortality Cases
Tidsramme: 12 weeks
The number of study participants who died while in the hospital was collected.
12 weeks
Day 84 Mortality
Tidsramme: Day 84
The number of participants who died prior to the end of the study (Day 84) was collected.
Day 84

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Emory University

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

  • Hovedetterforsker: Thomas Ziegler, MD, Emory University
  • Hovedetterforsker: Greg Martin, MD, MSc, Emory University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2011

Primær fullføring (Faktiske)

1. april 2014

Studiet fullført (Faktiske)

1. april 2014

Datoer for studieregistrering

Først innsendt

13. juni 2011

Først innsendt som oppfylte QC-kriteriene

13. juni 2011

Først lagt ut (Anslag)

14. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00049610

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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