Trial · NCT03096314
Vitamin D to Improve Outcomes by Leveraging Early Treatment
NCT03096314, Phase 3, Completed, Massachusetts General Hospital; results first posted 2020-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vitamin D to Improve Outcomes by Leveraging Early Treatment. Trials, record NCT03096314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03096314
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vitamin D to Improve Outcomes by Leveraging Early Treatment
- NCT number
- NCT03096314
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,358 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Acute Respiratory Distress Syndrome, Vitamin D Deficiency, Critical Illness
- Interventions
- Vitamin D3, Placebo
- First posted
- 2017-03-30
- Last updated
- 2020-01-27
- Results first posted
- 2020-01-27
- Limitations and caveats
The Data and Safety Monitoring Board recommended that the trial be stopped at the first interim analysis when the primary outcome of the study crossed a protocol specified futility boundary. This adaptive design element resulted in a completed study.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause, All-location Mortality to Day 90 | 90 days after randomization | Vital status of the patient at day 90 was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI). |
| Secondary | All-cause, All Location Mortality to Day 28 | Up to 28 days after randomization | This variable was calculated in participants who were reported alive at day 28. Vital status of the patient at day 28 was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, or review of obituaries. |
| Secondary | Hospital Mortality to Day 90 | Up to 90 days after randomization | Analysis of the number of participants who died prior to hospital discharge up to study day 90. |
| Secondary | Alive and Home (Prior Level of Care) at Day 90 | 90 days post randomization | This endpoint is the count of participants who have survived and are present at home, defined as pre-hospitalization level of care, at day 90. |
| Secondary | Hospital Length of Stay to Day 90 | 90 days after randomization | Number of days from enrollment to the day of study hospital discharge up to day 90. Only calculated for patients that survived through day 90. |
| Secondary | Healthcare Facility Length of Stay to Day 90 | 90 days after randomization | Healthcare facility length of stay is the time spent in another hospital or healthcare facility (e.g. long-term acute care \[LTAC\] hospitals or acute rehabilitation/skilled nursing facility), for the subgroup of participants that were discharged to another healthcare facility after the initial hospitalization. This measure is defined as the number of days from initial hospital discharge to the first facility discharge to home (pre-hospitalization level of care) up to day 90. Healthcare facility LOS is zero for patients discharged to home (pre-hospitalization level of care) from the study hospital. This endpoint will be analyzed only in survivors using SACE methods because healthcare facility length of stay in those who die during the follow-up period is non-informative for this endpoint. |
| Secondary | Ventilator-free Days (VFDs) to Day 28 | 28 days after randomization | In participants who survive 28 days, ventilator free days (VFDs) is defined as 28 minus duration of ventilation. Duration of ventilation is counted from the first study day of assisted breathing through the last day of assisted breathing provided the last day is prior to day 28. Or it is counted from the first study day of assisted breathing through day 28. For participants discharged with assisted ventilation prior to day 28, a phone call will be required to assess ventilator status at day 28. Participants discharged prior to day 28 (but not to home) on unassisted breathing will be assumed to remain on unassisted breathing through day 28. Isolated periods of ventilation briefer than 24 hours for surgical procedures and ventilation solely for sleep disordered breathing do not count towards duration of ventilation. In participants who never require assisted breathing, duration of ventilation is zero. Participants who do not survive 28 days will be assigned zero VFD. |
| Secondary | Health-related Quality of Life by EuroQol (EQ-5D-5L) | baseline to study day 90 | Changes in Quality of life score by EuroQol from baseline to day 90. Change was calculated as the value at day 90 minus the value at baseline. The EuroQol score is based on 5 dimensions of perceived problems: Mobility, Self-Care, Anxiety/Depression, Pain/discomfort, and Usual Activities. Problems with each area are assigned a level from 1-5 with level 1 being no problem and level 5 indicating extreme problems. A unique health state score is defined by combining 1 level from each of the 5 dimensions. Responses can be used to calculate a health utility score55 associated with the given health state that ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health). |
| Secondary | Number of Participants Who Developed (New) ARDS to Day 7 | Up to 7 days after randomization | Presence of ARDS determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio (i.e., imputed P/F ratio) and chest x-ray confirmation. PaO2 = partial pressure of arterial oxygen; FiO2 = percentage of inspired oxygen; SpO2 = peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. For participants with P/F \<300 or imputed P/F \<300, FiO2 ≥40%, and PEEP ≥5 cm H2O, we determined if hypoxemia was valid, acute, and not fully explained by congestive heart failure (CHF) or fluid overload. PEEP = positive end expiatory pressure. |
| Secondary | Severity of Acute Respiratory Distress Syndrome (ARDS) | 7 days after randomization | Severity of ARDS is determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio and confirmation of ARDS through chest x-ray reviews. The breakout of mild to severe was categorized as P/F or imputed P/F ratio of 201-300 (mild), 100-200 (moderate), or less than 100 (severe). This physiologic outcome is one of three key organ systems (respiratory, renal, and cardiovascular) used to assess change in organ failure severity from randomization up to study day 7. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-cause, All-location Mortality to Day 90 | 90 days after randomization | The primary analysis included subjects who had confirmed vitamin D deficiency by LC/MS/MS testing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-cause, All Location Mortality to Day 28 | Up to 28 days after randomization | participants | NUMBER | |
| SECONDARY | Hospital Mortality to Day 90 | Up to 90 days after randomization | Participant count is based on available data. | participants | NUMBER |
| SECONDARY | Alive and Home (Prior Level of Care) at Day 90 | 90 days post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital Length of Stay to Day 90 | 90 days after randomization | days | MEAN | |
| SECONDARY | Healthcare Facility Length of Stay to Day 90 | 90 days after randomization | This outcome was analyzed only in survivors using SACE methods because healthcare facility length of stay in those who die during the follow-up period is non-informative for this endpoint. | days | MEAN |
| SECONDARY | Ventilator-free Days (VFDs) to Day 28 | 28 days after randomization | Excludes subjects who never required assisted breathing or who did not survive 28 days (considered zero vent free days). | days | MEAN |
| SECONDARY | Health-related Quality of Life by EuroQol (EQ-5D-5L) | baseline to study day 90 | Subjects alive and able to be contacted at study day 90 and who had a baseline EQ-5D-5L assessment were analyzed. | score on a scale | MEAN |
| SECONDARY | Number of Participants Who Developed (New) ARDS to Day 7 | Up to 7 days after randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of Acute Respiratory Distress Syndrome (ARDS) | 7 days after randomization | Those subjects that developed new ARDS after randomization were analyzed for severity. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-cause, All-location Mortality to Day 90 | High Dose Vitamin D Formulation | 125 | Participants | ||
| All-cause, All-location Mortality to Day 90 | Placebo | 109 | Participants | ||
| All-cause, All Location Mortality to Day 28 | High Dose Vitamin D Formulation | 92 | participants | ||
| All-cause, All Location Mortality to Day 28 | Placebo | 69 | participants | ||
| Hospital Mortality to Day 90 | High Dose Vitamin D Formulation | 92 | participants | ||
| Hospital Mortality to Day 90 | Placebo | 72 | participants | ||
| Alive and Home (Prior Level of Care) at Day 90 | High Dose Vitamin D Formulation | 348 | Participants | ||
| Alive and Home (Prior Level of Care) at Day 90 | Placebo | 345 | Participants | ||
| Hospital Length of Stay to Day 90 | High Dose Vitamin D Formulation | 9.1 | Standard Deviation 9.2 | days | |
| Hospital Length of Stay to Day 90 | Placebo | 10.4 | Standard Deviation 11.0 | days |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screened Vitamin D Deficient | STARTED | High Dose Vitamin D Formulation | 690 | |
| Screened Vitamin D Deficient | STARTED | Placebo | 668 | |
| Screened Vitamin D Deficient | COMPLETED | High Dose Vitamin D Formulation | 681 | |
| Screened Vitamin D Deficient | COMPLETED | Placebo | 656 | |
| Screened Vitamin D Deficient | NOT COMPLETED | High Dose Vitamin D Formulation | 9 | |
| Screened Vitamin D Deficient | NOT COMPLETED | Placebo | 12 | |
| Confirmed Vitamin D Deficient | STARTED | High Dose Vitamin D Formulation | 538 | |
| Confirmed Vitamin D Deficient | STARTED | Placebo | 540 | |
| Confirmed Vitamin D Deficient | COMPLETED | High Dose Vitamin D Formulation | 531 | |
| Confirmed Vitamin D Deficient | COMPLETED | Placebo | 528 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events98
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 |
|---|---|---|---|---|---|---|
| other | Anemia Microcytic | Blood and lymphatic system disorders | High Dose Vitamin D Formulation | 1 | 690 | 2 |
| other | Anemia Microcytic | Blood and lymphatic system disorders | Placebo | 0 | 668 | 0 |
| other | Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | High Dose Vitamin D Formulation | 1 | 690 | 1 |
| other | Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 668 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | High Dose Vitamin D Formulation | 0 | 690 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | Placebo | 1 | 668 | 1 |
| other | Ventricular Tachycardia | Cardiac disorders | High Dose Vitamin D Formulation | 0 | 690 | 0 |
| other | Ventricular Tachycardia | Cardiac disorders | Placebo | 1 | 668 | 1 |
| other | Confidentiality | General disorders | High Dose Vitamin D Formulation | 1 | 690 | 1 |
| other | Confidentiality | General disorders | Placebo | 1 | 668 | 1 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose Vitamin D Formulation | 159 | 681 |
| Total, all-cause mortality | Placebo | 137 | 656 |
| Total, other adverse events | High Dose Vitamin D Formulation | 10 | 690 |
| Total, other adverse events | Placebo | 6 | 668 |
| Total, serious adverse events | High Dose Vitamin D Formulation | 14 | 690 |
| Total, serious adverse events | Placebo | 18 | 668 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31826336 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL123009 | CCC for NHLBI Prevention and Early Treatment of Acute Lung Injury PETAL Network | THOMPSON, BOYD TAYLOR; FOULKES, ANDREA S | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2014 to 2021 |
Source NIH RePORTER
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Dose Vitamin D Formulation vs Placebo: Hospital Mortality to Day 90 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: Falls to Day 90 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: Fall-related Fractures to Day 90 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: Alive and Home (Prior Level of Care) at Day 90 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: Kidney Stones to Day 90 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: All-cause, All-location Mortality to Day 90 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: Hypercalcemia to Day 14 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: New Renal Replacement Therapy (RRT) | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: All-cause, All Location Mortality to Day 28 | Trial comparisons |
| High Dose Vitamin D Formulation vs Placebo: deaths from any cause | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
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.
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