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

10 november 2016 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

  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.

Studietyp

Interventionell

Inskrivning (Faktisk)

31

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Emory University Hospital
      • Atlanta, Georgia, Förenta staterna, 30308
        • Emory University Hospital Midtown

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Enteral vitamin D3 50,000 IU
An arm where subjects receive 50,000 IU of Vitamin D for 5 days.
Läkemedel: Enteral Vitamin D3 50,000 IU
Enteral Vitamin D3 50,000IU x 5 days (total dose 250,000IU)
Experimentell: Enteral Vitamin D3 100,000 IU
Arm where subjects receive 100,000 IU of Vitamin D for 5 days
Läkemedel: Enteral Vitamin D3 100,000IU
Enteral Vitamin D3 100,000IU over 5 days (total 500,000IU)
Placebo-jämförare: Inactive Substance
Arm where patients receive inactive substance for 5 days.
Övrig: Inactive substance
Inactive substance given enterally for 5 days.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Plasma LL-37 Levels
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 12 weeks
The number of study participants who had a hospital acquired infection.
12 weeks
Number of Hospital Mortality Cases
Tidsram: 12 weeks
The number of study participants who died while in the hospital was collected.
12 weeks
Day 84 Mortality
Tidsram: Day 84
The number of participants who died prior to the end of the study (Day 84) was collected.
Day 84

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Emory University

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2011

Primärt slutförande (Faktisk)

1 april 2014

Avslutad studie (Faktisk)

1 april 2014

Studieregistreringsdatum

Först inskickad

13 juni 2011

Först inskickad som uppfyllde QC-kriterierna

13 juni 2011

Första postat (Uppskatta)

14 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 januari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 november 2016

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00049610

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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