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Trial · NCT01372995

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Plasma 25(OH)D Concentration >30ng/mL at BaselineBaseline
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.
participantsNUMBER
PRIMARYNumber of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7Day 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.
participantsNUMBER
PRIMARYNumber of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14Day 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.
participantsNUMBER
PRIMARYNumber of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21Day 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.
participantsNUMBER
PRIMARYNumber of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28Day 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.
participantsNUMBER
PRIMARYNumber of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84Day 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.
participantsNUMBER
SECONDARYChange in Plasma LL-37 LevelsBaseline, Day 7, Day 14For 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/mLMEDIAN
SECONDARYDuration of Time on Ventilator12 weeksdaysMEAN
SECONDARYDuration of Time in Intensive Care Unit (ICU)12 weeksdaysMEAN
SECONDARYDuration of Time in Hospital12 weeksdaysMEAN
SECONDARYChange in Sequential Organ Failure Assessment (SOFA) ScoreBaseline, Day 7
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..
units on a scaleMEAN
SECONDARYNumber of Hospital Acquired Infections12 weeksparticipantsNUMBER
SECONDARYNumber of Hospital Mortality Cases12 weeksThe number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11.participantsNUMBER
SECONDARYDay 84 MortalityDay 84The 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.participantsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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