Trial · NCT01372995
Vitamin D in Ventilated ICU Patients
NCT01372995, Phase 2, Completed, Emory University; results first posted 2017-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vitamin D in Ventilated ICU Patients. Trials, record NCT01372995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01372995
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vitamin D in Ventilated ICU Patients
- NCT number
- NCT01372995
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Respiratory Failure
- Interventions
- Enteral Vitamin D3 50,000 IU, Enteral Vitamin D3 100,000IU, Inactive substance
- First posted
- 2011-06-14
- Last updated
- 2017-01-09
- Results first posted
- 2017-01-09
- Limitations and caveats
- Limitations to generalizability of this pilot study include the small sample size and imbalances in chronic conditions between treatment arms at study entry.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline | Baseline | 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. |
| Primary | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7 | Day 7 | 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. |
| Primary | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14 | Day 14 | 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. |
| Primary | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21 | Day 21 | 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. |
| Primary | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28 | Day 28 | 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. |
| Primary | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84 | Day 84 | 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. |
| Secondary | Change in Plasma LL-37 Levels | Baseline, Day 7, Day 14 | Plasma LL-37 was measured at Baseline, Day 7 and Day 14. |
| Secondary | Duration of Time on Ventilator | 12 weeks | 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. |
| Secondary | Duration of Time in Intensive Care Unit (ICU) | 12 weeks | 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. |
| Secondary | Duration of Time in Hospital | 12 weeks | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline | Baseline | 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. | participants | NUMBER |
| PRIMARY | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7 | Day 7 | 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. | participants | NUMBER |
| PRIMARY | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14 | Day 14 | 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. | participants | NUMBER |
| PRIMARY | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21 | Day 21 | 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. | participants | NUMBER |
| PRIMARY | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28 | Day 28 | 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. | participants | NUMBER |
| PRIMARY | Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84 | Day 84 | 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. | participants | NUMBER |
| SECONDARY | Change in Plasma LL-37 Levels | Baseline, Day 7, Day 14 | 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. | ng/mL | MEDIAN |
| SECONDARY | Duration of Time on Ventilator | 12 weeks | days | MEAN | |
| SECONDARY | Duration of Time in Intensive Care Unit (ICU) | 12 weeks | days | MEAN | |
| SECONDARY | Duration of Time in Hospital | 12 weeks | days | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline | Placebo | 2 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline | 250,000 IU of Vitamin D3 | 2 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline | 500,000 IU of Vitamin D3 | 1 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7 | Placebo | 2 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7 | 250,000 IU of Vitamin D3 | 4 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7 | 500,000 IU of Vitamin D3 | 9 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14 | Placebo | 2 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14 | 250,000 IU of Vitamin D3 | 5 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14 | 500,000 IU of Vitamin D3 | 5 | participants | ||
| Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21 | Placebo | 1 | participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | STARTED | 250,000 IU of Vitamin D3 | 10 | |
| Overall Study | STARTED | 500,000 IU of Vitamin D3 | 11 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | COMPLETED | 250,000 IU of Vitamin D3 | 9 | |
| Overall Study | COMPLETED | 500,000 IU of Vitamin D3 | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | 250,000 IU of Vitamin D3 | 1 | |
| Overall Study | NOT COMPLETED | 500,000 IU of Vitamin D3 | 1 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Re-hospitalization | General disorders | Placebo | 1 | 10 | 1 |
| serious | Re-hospitalization | General disorders | 250,000 IU of Vitamin D3 | 1 | 9 | 1 |
| serious | Re-hospitalization | General disorders | 500,000 IU of Vitamin D3 | 0 | 11 | 0 |
| serious | Death | General disorders | Placebo | 0 | 10 | 0 |
| serious | Death | General disorders | 250,000 IU of Vitamin D3 | 0 | 9 | 0 |
| serious | Death | General disorders | 500,000 IU of Vitamin D3 | 1 | 11 | 1 |
| serious | Cardiopulmonary arrest | Cardiac disorders | Placebo | 0 | 10 | 0 |
| serious | Cardiopulmonary arrest | Cardiac disorders | 250,000 IU of Vitamin D3 | 0 | 9 | 0 |
| serious | Cardiopulmonary arrest | Cardiac disorders | 500,000 IU of Vitamin D3 | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 250,000 IU of Vitamin D3 | ||
| Total, all-cause mortality | 500,000 IU of Vitamin D3 | ||
| Total, other adverse events | Placebo | 0 | 10 |
| Total, other adverse events | 250,000 IU of Vitamin D3 | 0 | 9 |
| Total, other adverse events | 500,000 IU of Vitamin D3 | 0 | 11 |
| Total, serious adverse events | Placebo | 1 | 10 |
| Total, serious adverse events | 250,000 IU of Vitamin D3 | 1 | 9 |
| Total, serious adverse events | 500,000 IU of Vitamin D3 | 2 | 11 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01372995
GET https://conductscience.org/api/trials/v1/NCT01372995/results?page=2