Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

November 5, 2020 updated by: David Leaf, Brigham and Women's Hospital
Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 18
  • Severe sepsis or septic shock
  • Central venous catheter (for blood drawing)

Exclusion Criteria:

  • Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours
  • Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses >1,000 I.U. per day or activated vitamin D at any dose
  • History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis
  • Expected to die or leave the ICU within 48 hours
  • History of hypersensitivity or any allergic reaction to calcitriol
  • End stage renal disease
  • Acute Kidney Injury receiving intermittent renal replacement therapy
  • Enrolled in a competing study
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcitriol
Calcitriol 2mcg IV x 1
Drug: Calcitriol
Placebo Comparator: Placebo
Normal saline 2cc IV x 1
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Interleukin-6 (IL-6) Levels at 48 Hours
Time Frame: 48 hours
48 hours
Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours
Time Frame: 48 hours
NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: David E Leaf, M.D., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P001755

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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