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

NCT ID: NCT01689441

Last Updated: 2020-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Sepsis or Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcitriol

Calcitriol 2mcg IV x 1

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Placebo

Normal saline 2cc IV x 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Calcitriol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Leaf

Assistant Professor of Medicine, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David E Leaf, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25029202 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/25029202

Link to manuscript in pubmed

Other Identifiers

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2012P001755

Identifier Type: -

Identifier Source: org_study_id