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NCT03733418 · ClinicalTrials.gov registry record

Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients

A clinical trial, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
95
Enrollment target

NCT03733418: Completed study, sponsored by Vanderbilt University Medical Center.

NCT03733418 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 95 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03733418 has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
95 participants
Enrollment target

Study Summary

This ancillary study will determine if early administration of a single high-dose (540,000 IU) oral vitamin D3 (cholecalciferol) treatment improves 12-month global cognition and executive function as determined by comprehensive neuropsychological testing in 140 critically ill patients with Vitamin D deficiency at enrollment.

Primary Outcome

The RBANS is a comprehensive neuropsychological battery for the evaluation of global cognition and has been validated in subjects with mild cognitive impairment, moderate to severe traumatic brain injuries, vascular dementias, and Alzheimer's disease. It specifically tests for for immediate and delayed memory, attention, visuospatial construction, and language. Scores range from 0 to 160 with 100 representing the population average. Higher score represents better cognition.

Interventions

  • DRUG Placebo
  • DRUG 540,000 IU vitamin D3

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2018-11-01
Est. Completion 2020-02-21

What the finished NCT03733418 record still lists

NCT03733418 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 95 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03733418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03733418 about?

NCT03733418 is a clinical study titled "Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients". This ancillary study will determine if early administration of a single high-dose (540,000 IU) oral vitamin D3 (cholecalciferol) treatment improves 12-month global cognition and executive function as determined by comprehensive neuropsychological testing in 140 critically ill patients with Vitamin D...

What is the current status of trial NCT03733418?

This trial is currently completed. The enrollment target is 95 participants. The study started on 2018-11-01. Estimated completion is 2020-02-21.

What interventions are being tested in trial NCT03733418?

The interventions under investigation include: Placebo (DRUG), 540,000 IU vitamin D3 (DRUG).

Who is sponsoring clinical trial NCT03733418?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03733418, the US trial registry maintained by the National Library of Medicine. NCT03733418 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.