Trial Outcomes & Findings for Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (NCT NCT02962102)
NCT ID: NCT02962102
Last Updated: 2025-09-29
Results Overview
All-cause mortality within 7 days following randomization
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
7 days
Results posted on
2025-09-29
Participant Flow
Participant milestones
| Measure |
Calcifediol
Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
Calcifediol: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
|
Calcitriol
Calcitriol 4mcg orally daily x 5 days
Calcitriol: Calcitriol 4mcg orally daily x 5
|
Placebo
Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) orally daily x 5
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
49
|
|
Overall Study
COMPLETED
|
51
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
Calcifediol: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg orally daily x 5 days
Calcitriol: Calcitriol 4mcg orally daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) orally daily x 5
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
65 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Baseline estimated glomerular filtration rate (eGFR)
|
94 ml/min/1.73m^2
n=5 Participants
|
98 ml/min/1.73m^2
n=7 Participants
|
94 ml/min/1.73m^2
n=5 Participants
|
95 ml/min/1.73m^2
n=4 Participants
|
|
APACHE II score
|
26 units on a scale
n=5 Participants
|
25 units on a scale
n=7 Participants
|
27 units on a scale
n=5 Participants
|
25 units on a scale
n=4 Participants
|
|
Invasive mechanical ventilation
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Vasopressors/inotropes
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Acute kidney injury
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Plasma 25-hydroxyvitamin D
|
18.8 ng/ml
n=5 Participants
|
17.3 ng/ml
n=7 Participants
|
14.5 ng/ml
n=5 Participants
|
16.5 ng/ml
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysAll-cause mortality within 7 days following randomization
Outcome measures
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
Death Within 7 Days
|
4 Participants
|
9 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 7 daysNumber of participants who received renal replacement therapy within 7 days following randomization
Outcome measures
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
Number of Participants Who Received Renal Replacement Therapy Within 7 Days
|
1 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 7 daysAverage percentage change in serum creatinine assessed on days 1-7 as compared to day 0
Outcome measures
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
Relative Average Change in Serum Creatinine From Day 0 to Days 1-7
|
-2.3 Relative average percent increase
Interval -20.7 to 18.3
|
-7.1 Relative average percent increase
Interval -18.1 to 12.3
|
-7.4 Relative average percent increase
Interval -21.5 to 10.4
|
SECONDARY outcome
Timeframe: 7 daysAny of the following: 1) an increase in serum creatinine ≥50% compared to the immediate pre-randomization value; 2) new or progressive stage of oliguria; or 3) receipt of renal replacement therapy. Oliguria stages 1, 2, and 3 are defined as urine output (UOP) \<0.5 ml/kg/h for 6-12h, \<0.5 ml/kg/h for \>12h, and \<0.3 ml/kg/h for ≥24h or anuria for ≥12h, respectively.
Outcome measures
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
Number of Participants With New or Worsening Stage of AKI, Defined by KDIGO Guidelines
|
20 Participants
|
23 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 7 daysHighest serum creatinine value on days 1 to 7
Outcome measures
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
Peak Serum Creatinine (mg/dl)
|
1.2 mg/dl
Interval 0.8 to 1.5
|
1.3 mg/dl
Interval 0.8 to 1.9
|
1.2 mg/dl
Interval 0.9 to 1.8
|
SECONDARY outcome
Timeframe: 28 daysAll-cause mortality assessed during the 28 days following randomization
Outcome measures
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
28-day Mortality
|
10 Participants
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 28 days28 minus the number of days in the ICU or hospital, with 0 assigned to patients who die before 28 days
Outcome measures
| Measure |
Calcifediol
n=51 Participants
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 Participants
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 Participants
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
ICU- and Hospital-free Days
Hospital-free days
|
5 Days
Interval 0.0 to 17.0
|
4 Days
Interval 0.0 to 15.0
|
0 Days
Interval 0.0 to 15.0
|
|
ICU- and Hospital-free Days
ICU-free days
|
20 Days
Interval 2.0 to 25.0
|
16 Days
Interval 0.0 to 25.0
|
11 Days
Interval 0.0 to 22.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysComposite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysComposite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysComposite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysComposite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysComposite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Outcome measures
Outcome data not reported
Adverse Events
Calcifediol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 10 deaths
Calcitriol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 16 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcifediol
n=51 participants at risk
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Calcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
|
Calcitriol
n=50 participants at risk
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Calcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5
|
Placebo
n=49 participants at risk
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Placebos: Placebo (medium chain triglyceride oil) daily x 5
|
|---|---|---|---|
|
Endocrine disorders
Hypercalcemia
|
2.0%
1/51 • 7 days for hypercalcemia and 28 days for all-cause mortality
|
2.0%
1/50 • 7 days for hypercalcemia and 28 days for all-cause mortality
|
0.00%
0/49 • 7 days for hypercalcemia and 28 days for all-cause mortality
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place