Trial Outcomes & Findings for Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis (NCT NCT01689441)

NCT ID: NCT01689441

Last Updated: 2020-11-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 67 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2020-11-10

Participant Flow

Participant milestones

Measure	Calcitriol Calcitriol 2mcg IV x 1 Calcitriol	Placebo Normal saline 2cc IV x 1 Placebo
Overall Study STARTED	36	31
Overall Study COMPLETED	36	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Calcitriol n=36 Participants Calcitriol 2mcg IV x 1 Calcitriol	Placebo n=31 Participants Normal saline 2cc IV x 1 Placebo	Total n=67 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	58 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	31 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Calcitriol n=36 Participants Calcitriol 2mcg IV x 1 Calcitriol	Placebo n=31 Participants Normal saline 2cc IV x 1 Placebo
Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours	76 ng/ml Interval 60.0 to 94.0	82 ng/ml Interval 70.0 to 100.0

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Calcitriol n=36 Participants Calcitriol 2mcg IV x 1 Calcitriol	Placebo n=31 Participants Normal saline 2cc IV x 1 Placebo
Plasma Interleukin-6 (IL-6) Levels at 48 Hours	41 pg/ml Interval 25.0 to 92.0	32 pg/ml Interval 21.0 to 85.0

SECONDARY outcome

Timeframe: 48 hours

Population: The discrepancy in "number of participants analyzed" for this outcome vs. other outcomes is due to urine samples not being available in all participants

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.

Outcome measures

Measure	Calcitriol n=30 Participants Calcitriol 2mcg IV x 1 Calcitriol	Placebo n=24 Participants Normal saline 2cc IV x 1 Placebo
Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours	0.6 mg/mg Interval 0.2 to 3.1	0.7 mg/mg Interval 0.3 to 2.7

Adverse Events

Calcitriol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Leaf, MD, MMSc

Brigham and Women's Hospital

Phone: 617-732-5500

Email: deleaf@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place