Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01689441
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : October 30, 2014
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sushrut S Waikar, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Sepsis or Septic Shock Drug: Calcitriol Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Calcitriol

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



Primary Outcome Measures :
  1. Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Plasma Interleukin-6 (IL-6) Levels at 48 Hours [ Time Frame: 48 hours ]
  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689441


Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Principal Investigator: David E Leaf, M.D. Brigham and Women's Hospital

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Sushrut S Waikar, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01689441     History of Changes
Other Study ID Numbers: 2012P001755
First Posted: September 21, 2012    Key Record Dates
Results First Posted: October 30, 2014
Last Update Posted: September 15, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Critical Illness
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Shock
Calcitriol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents