Authorised Therapeutic confirmatory (Phase III) Adult critically ill patients with severe vitamin D deficiency

Effect of high-dose vitamin D on 28-day mortality in adult critically ill patients with severe vitamin D deficiency

EU CTIS ID: 2024-514556-32-00

What this study is testing

To test if high-dose vitamin D3 is beneficial for the clinical outcome of critically ill adult patients with severe vitamin D deficiency 28-day mortality

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age ≥18 years
  • Expected primary ICU stay ≥ 48 hours
  • ≤ 72 hours in primary ICU at screening blood sample
  • Severe vitamin D deficiency (≤12 ng/ml or undetectable)

You likely can't join if

  • Hypercalcemia at inclusion (total Ca > 2.65 mmol/l, ionized Ca > 1.35 mmol/l)
  • Study medication intake not possible (mask, ileus, residual volume high)
  • History of kidney stones (≤ 1 year)
  • Granulomatous disease (active tuberculosis or sarcoidosis)
  • Pregnant/nursing
  • Other reasons* (DNR= do not resuscitate, relevant psychiatric disease, prisoner)
See the full eligibility criteria
Who can join
  • Age ≥18 years
  • Expected primary ICU stay ≥ 48 hours
  • ≤ 72 hours in primary ICU at screening blood sample
  • Severe vitamin D deficiency (≤12 ng/ml or undetectable)
What rules you out
  • Hypercalcemia at inclusion (total Ca > 2.65 mmol/l, ionized Ca > 1.35 mmol/l)
  • Study medication intake not possible (mask, ileus, residual volume high)
  • History of kidney stones (≤ 1 year)
  • Granulomatous disease (active tuberculosis or sarcoidosis)
  • Pregnant/nursing
  • Other reasons* (DNR= do not resuscitate, relevant psychiatric disease, prisoner)
  • Hypersensitivity to drug or excipient

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.