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Vitamin D in Ventilated ICU Patients (R21 HL-110044)

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: NCT01372995
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Greg S. Martin, M.D., M.Sc., Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Respiratory Failure
Interventions Drug: Enteral Vitamin D3 50,000 IU
Drug: Enteral Vitamin D3 100,000IU
Other: Inactive substance
Enrollment 31
Recruitment Details Study participants were recruited from critical care units at three hospitals in Atlanta, Georgia. 658 patients were assessed for eligibility, of these 562 did not meet inclusion and exclusion criteria. 65 eligible patients declined to participate while 31 gave informed consent and were randomized to one of the three study arms.
Pre-assignment Details  
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description Participants randomized to receive an inactive substance administered enterally for 5 days Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Period Title: Overall Study
Started 10 10 11 [1]
Completed 10 9 10 [2]
Not Completed 0 1 1
Reason Not Completed
Spouse withdrew participant from study             0             1             0
Physician Decision             0             0             1
[1]
One participant was transferred to comfort care prior to completing the intervention.
[2]
The transferred participant was included in the intent to treat analyses.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3 Total
Hide Arm/Group Description Participants randomized to receive an inactive substance administered enterally for 5 days Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally Total of all reporting groups
Overall Number of Baseline Participants 10 9 11 30
Hide Baseline Analysis Population Description
The participant randomized to the 250,000 IU of Vitamin D3 study arm, whose spouse withdrew consent to participate in the study, is not represented in the Baseline Analysis Population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  50.0%
5
  55.6%
4
  36.4%
14
  46.7%
>=65 years
5
  50.0%
4
  44.4%
7
  63.6%
16
  53.3%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
Female
4
  40.0%
4
  44.4%
3
  27.3%
11
  36.7%
Male
6
  60.0%
5
  55.6%
8
  72.7%
19
  63.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
African American 4 7 3 14
Caucasian 5 2 8 15
American Indian/Alaskan 1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 11 participants 30 participants
10 9 11 30
Vitamin D at baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
Deficient (<20 ng/mL) 5 3 5 13
Insufficient (20-30 ng/mL) 3 4 5 12
Sufficient (>30 ng/mL) 2 2 1 5
Coronary Artery Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
Coronary Artery Disease Present 1 2 7 10
No Coronary Artery Disease 9 7 4 20
Congestive Heart Failure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
Congestive Heart Failure Present 1 2 5 8
No Congestive Heart Failure 9 7 6 22
Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
Diabetes Present 4 1 2 7
No Diabetes 6 8 9 23
Chronic Obstructive Pulmonary Disease (COPD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
COPD Present 2 1 4 7
No COPD 8 8 7 23
Asthma  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 30 participants
Asthma Present 1 1 0 2
No Asthma 9 8 11 28
1.Primary Outcome
Title Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline
Hide Description The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. At the baseline time point, 10 patients were randomized to the placebo arm, 9 to the arm receiving 250,000 IU of Vitamin D3, and 11 to the arm receiving 500,000 of Vitamin D3.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 9 11
Measure Type: Number
Unit of Measure: participants
2 2 1
2.Primary Outcome
Title Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7
Hide Description The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 9 6 9
Measure Type: Number
Unit of Measure: participants
2 4 9
3.Primary Outcome
Title Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14
Hide Description The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed for each time point decreased over the course of the study as participants were discharged from the hospital.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 8 6 5
Measure Type: Number
Unit of Measure: participants
2 5 5
4.Primary Outcome
Title Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21
Hide Description The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement.
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 4 4 2
Measure Type: Number
Unit of Measure: participants
1 3 2
5.Primary Outcome
Title Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28
Hide Description The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 3 2 1
Measure Type: Number
Unit of Measure: participants
0 2 1
6.Primary Outcome
Title Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84
Hide Description The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 1 2 1
Measure Type: Number
Unit of Measure: participants
1 0 0
7.Secondary Outcome
Title Change in Plasma LL-37 Levels
Hide Description Plasma LL-37 was measured at Baseline, Day 7 and Day 14.
Time Frame Baseline, Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
For the Day 14 analysis there were 8 participants in the Placebo arm, 6 participants in the 250,000 of Vitamin D arm, and 5 participants in the 500,000 of Vitamin D arm.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 8 6 5
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Day 7 Compared to Baseline
-3.8
(-18.9 to 26.9)
6.0
(-13.4 to 39.2)
-13.5
(-48.4 to 37.4)
Day 14 Compared to Baseline
1.1
(-24.6 to 10.8)
-12.3
(-36.1 to 8.1)
-6.0
(-27.3 to 2.0)
8.Secondary Outcome
Title Duration of Time on Ventilator
Hide Description The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 9 11
Mean (Standard Deviation)
Unit of Measure: days
20  (15) 12  (10) 14  (10)
9.Secondary Outcome
Title Duration of Time in Intensive Care Unit (ICU)
Hide Description The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 9 11
Mean (Standard Deviation)
Unit of Measure: days
23  (14) 17  (14) 15  (10)
10.Secondary Outcome
Title Duration of Time in Hospital
Hide Description The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 9 11
Mean (Standard Deviation)
Unit of Measure: days
36  (19) 25  (14) 18  (11)
11.Secondary Outcome
Title Change in Sequential Organ Failure Assessment (SOFA) Score
Hide Description Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score.
Time Frame Baseline, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
SOFA score obtained daily while in the ICU. The portion of the study participants included in the analysis of the change in SOFA score between Baseline and Day 7 is limited to participants having values for both time points..
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 7 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2  (3) -3  (3) -2  (3)
12.Secondary Outcome
Title Number of Hospital Acquired Infections
Hide Description The number of study participants who had a hospital acquired infection.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 9 11
Measure Type: Number
Unit of Measure: participants
3 3 2
13.Secondary Outcome
Title Number of Hospital Mortality Cases
Hide Description The number of study participants who died while in the hospital was collected.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 9 10
Measure Type: Number
Unit of Measure: participants
1 0 1
14.Secondary Outcome
Title Day 84 Mortality
Hide Description The number of participants who died prior to the end of the study (Day 84) was collected.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11, as one participant withdrew.
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description:
Participants randomized to receive an inactive substance administered enterally for 5 days
Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Number of Participants Analyzed 10 9 10
Measure Type: Number
Unit of Measure: participants
2 1 4
Time Frame Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution.
Adverse Event Reporting Description As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.
 
Arm/Group Title Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Hide Arm/Group Description Participants randomized to receive an inactive substance administered enterally for 5 days Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally. Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.
All-Cause Mortality
Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      1/9 (11.11%)      2/11 (18.18%)    
Cardiac disorders       
Cardiopulmonary arrest * [1]  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1
General disorders       
Re-hospitalization * [2]  1/10 (10.00%)  1 1/9 (11.11%)  1 0/11 (0.00%)  0
Death * [3]  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Cardiopulmonary arrest
[2]
Re-hospitalization within 30 days of study drug discontinuation
[3]
Death within 30 days of study drug discontinuation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 250,000 IU of Vitamin D3 500,000 IU of Vitamin D3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)      0/11 (0.00%)    
Limitations to generalizability of this pilot study include the small sample size and imbalances in chronic conditions between treatment arms at study entry.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jenny Han, MD
Organization: Emory University
Phone: 404-616-0821
EMail: jehan2@emory.edu
Publications:
Layout table for additonal information
Responsible Party: Greg S. Martin, M.D., M.Sc., Emory University
ClinicalTrials.gov Identifier: NCT01372995    
Other Study ID Numbers: IRB00049610
First Submitted: June 13, 2011
First Posted: June 14, 2011
Results First Submitted: July 28, 2016
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017