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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Vitamin D in Ventilated ICU Patients

Short name R21 HL-110044

NCTNCT01372995 (opens ClinicalTrials.gov in a new tab)Other idIRB00049610
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures LL-37, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 2
Enrollment
31 participants (actual)
Sponsor
Emory University · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jul 2011
Primary completion
Apr 2014
Completion
Apr 2014
First posted
14 Jun 2011 (estimated)
Last update posted
9 Jan 2017 (estimated)
Conditions
Respiratory Failure

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 2

    R21 HL-110044

    NCT01372995

    Jul 2011 to Apr 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Enteral Vitamin D3 50,000 IUDrug
  • Enteral Vitamin D3 100,000IUDrug
  • Inactive substanceOther

Arms3

  • Experimental

    Enteral vitamin D3 50,000 IU

    An arm where subjects receive 50,000 IU of Vitamin D for 5 days.

  • Experimental

    Enteral Vitamin D3 100,000 IU

    Arm where subjects receive 100,000 IU of Vitamin D for 5 days

  • Placebo comparator

    Inactive Substance

    Arm where patients receive inactive substance for 5 days.

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline

    Time frame · Baseline

    Registry description

    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.

  2. Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7

    Time frame · Day 7

    Registry description

    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.

  3. Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14

    Time frame · Day 14

    Registry description

    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.

  4. Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21

    Time frame · Day 21

    Registry description

    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.

  5. Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28

    Time frame · Day 28

    Registry description

    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.

  6. Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84

    Time frame · Day 84

    Registry description

    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.

Secondary outcomes(8)

  1. Change in Plasma LL-37 Levels

    Time frame · Baseline, Day 7, Day 14

    Registry description

    Plasma LL-37 was measured at Baseline, Day 7 and Day 14.

  2. Duration of Time on Ventilator

    Time frame · 12 weeks

    Registry description

    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.

  3. Duration of Time in Intensive Care Unit (ICU)

    Time frame · 12 weeks

    Registry description

    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.

  4. Duration of Time in Hospital

    Time frame · 12 weeks

    Registry description

    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.

  5. Change in Sequential Organ Failure Assessment (SOFA) Score

    Time frame · Baseline, Day 7

    Registry description

    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.

  6. Number of Hospital Acquired Infections

    Time frame · 12 weeks

    Registry description

    The number of study participants who had a hospital acquired infection.

  7. Number of Hospital Mortality Cases

    Time frame · 12 weeks

    Registry description

    The number of study participants who died while in the hospital was collected.

  8. Day 84 Mortality

    Time frame · Day 84

    Registry description

    The number of participants who died prior to the end of the study (Day 84) was collected.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline

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

GroupValue (participants)
Placebo2
250,000 IU of Vitamin D32
500,000 IU of Vitamin D31
Primary outcomeNumber· Day 7

Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7

GroupValue (participants)
Placebo2
250,000 IU of Vitamin D34
500,000 IU of Vitamin D39
Primary outcomeNumber· Day 14

Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14

GroupValue (participants)
Placebo2
250,000 IU of Vitamin D35
500,000 IU of Vitamin D35
Primary outcomeNumber· Day 21

Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21

GroupValue (participants)
Placebo1
250,000 IU of Vitamin D33
500,000 IU of Vitamin D32
Primary outcomeNumber· Day 28

Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28

GroupValue (participants)
Placebo0
250,000 IU of Vitamin D32
500,000 IU of Vitamin D31
Primary outcomeNumber· Day 84

Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84

GroupValue (participants)
Placebo1
250,000 IU of Vitamin D30
500,000 IU of Vitamin D30
Secondary and other outcome results(2)
Secondary outcomeMedian· Baseline, Day 7, Day 14

Change in Plasma LL-37 Levels

GroupValue (ng/mL)
Placebo-3.8
250,000 IU of Vitamin D36.0
500,000 IU of Vitamin D3-13.5
Secondary outcomeMean· 12 weeks

Duration of Time on Ventilator

GroupValue (days)Spread
Placebo2015
250,000 IU of Vitamin D31210
500,000 IU of Vitamin D31410

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants randomized to receive an inactive substance administered enterally for 5 days–1 / 100 / 10
250,000 IU of Vitamin D3Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally.–1 / 90 / 9
500,000 IU of Vitamin D3Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.–2 / 110 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

More studies

4 studies on this page

PubMed tag: none · 2016

High Dose Vitamin D Administration in Ventilated Intensive Care Unit Patients: A Pilot Double Blind Randomized Controlled Trial.

Han et al. 2016Journal of clinical & translational endocrinologycited by 114

PMID 27419080PMC4939707DOI 10.1016/j.jcte.2016.04.004PUB-27419080

Free to read · publisher termsCC BY-NC-ND
Read at source

PubMed tag: none · 2010

The human cathelicidin LL-37 preferentially promotes apoptosis of infected airway epithelium.

Barlow et al. 2010American journal of respiratory cell and molecular biologycited by 87

PMID 20097832PMC2993089DOI 10.1165/rcmb.2009-0250ocPUB-20097832

Rights unknown
Source link

PubMed tag: none · 2009

Alterations in vitamin D status and anti-microbial peptide levels in patients in the intensive care unit with sepsis.

Jeng et al. 2009Journal of translational medicinecited by 298

PMID 19389235PMC2684740DOI 10.1186/1479-5876-7-28PUB-19389235

CC BY
Download PDF

Indexing hint: Review · 2005

Human antimicrobial peptides: defensins, cathelicidins and histatins.

De Smet et al. 2005Biotechnology letterscited by 345

PMID 16215847DOI 10.1007/s10529-005-0936-5PUB-16215847

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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