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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Severe Sepsis or Septic Shock
Interventions Drug: Calcitriol
Drug: Placebo
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcitriol Placebo
Hide Arm/Group Description

Calcitriol 2mcg IV x 1

Calcitriol

Normal saline 2cc IV x 1

Placebo

Period Title: Overall Study
Started 36 31
Completed 36 31
Not Completed 0 0
Arm/Group Title Calcitriol Placebo Total
Hide Arm/Group Description

Calcitriol 2mcg IV x 1

Calcitriol

Normal saline 2cc IV x 1

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 36 31 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 36 participants 31 participants 67 participants
68
(54 to 70)
58
(49 to 69)
64
(50 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 67 participants
Female
14
  38.9%
16
  51.6%
30
  44.8%
Male
22
  61.1%
15
  48.4%
37
  55.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 31 participants 67 participants
36 31 67
1.Primary Outcome
Title Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours
Hide Description [Not Specified]
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcitriol Placebo
Hide Arm/Group Description:

Calcitriol 2mcg IV x 1

Calcitriol

Normal saline 2cc IV x 1

Placebo

Overall Number of Participants Analyzed 36 31
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
76
(60 to 94)
82
(70 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcitriol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Plasma Interleukin-6 (IL-6) Levels at 48 Hours
Hide Description [Not Specified]
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcitriol Placebo
Hide Arm/Group Description:

Calcitriol 2mcg IV x 1

Calcitriol

Normal saline 2cc IV x 1

Placebo

Overall Number of Participants Analyzed 36 31
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
41
(25 to 92)
32
(21 to 85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcitriol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours
Hide Description 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.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The discrepancy in "number of participants analyzed" for this outcome vs. other outcomes is due to urine samples not being available in all participants
Arm/Group Title Calcitriol Placebo
Hide Arm/Group Description:

Calcitriol 2mcg IV x 1

Calcitriol

Normal saline 2cc IV x 1

Placebo

Overall Number of Participants Analyzed 30 24
Median (Inter-Quartile Range)
Unit of Measure: mg/mg
0.6
(0.2 to 3.1)
0.7
(0.3 to 2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcitriol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcitriol Placebo
Hide Arm/Group Description

Calcitriol 2mcg IV x 1

Calcitriol

Normal saline 2cc IV x 1

Placebo

All-Cause Mortality
Calcitriol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Calcitriol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calcitriol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/31 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: David Leaf, MD, MMSc
Organization: Brigham and Women's Hospital
Phone: 617-732-5500
Responsible Party: Sushrut S Waikar, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01689441     History of Changes
Other Study ID Numbers: 2012P001755
First Submitted: September 18, 2012
First Posted: September 21, 2012
Results First Submitted: October 27, 2014
Results First Posted: October 30, 2014
Last Update Posted: September 15, 2016