NCT01689441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 30, 2014

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

September 18, 2012

Results QC Date

October 27, 2014

Last Update Submit

November 5, 2020

Conditions

Severe Sepsis or Septic Shock

Outcome Measures

Primary Outcomes (1)

  • Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours

    48 hours

Secondary Outcomes (2)

  • Plasma Interleukin-6 (IL-6) Levels at 48 Hours

    48 hours

  • Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours

    48 hours

Study Arms (2)

Calcitriol

EXPERIMENTAL

Calcitriol 2mcg IV x 1

Drug: Calcitriol

Placebo

PLACEBO COMPARATOR

Normal saline 2cc IV x 1

Drug: Placebo

Interventions

CalcitriolDRUG
Calcitriol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Leaf DE, Raed A, Donnino MW, Ginde AA, Waikar SS. Randomized controlled trial of calcitriol in severe sepsis. Am J Respir Crit Care Med. 2014 Sep 1;190(5):533-41. doi: 10.1164/rccm.201405-0988OC.

    PMID: 25029202RESULT

Related Links

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
David Leaf, MD, MMSc
Organization
Brigham and Women's Hospital
deleaf@partners.org
617-732-5500

Study Officials

  • David E Leaf, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 21, 2012

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 10, 2020

Results First Posted

October 30, 2014

Record last verified: 2020-11

Locations

US(1)