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Vitamin D Status in Patients With Severe Sepsis

NCT02684487 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-05-05

No results posted yet for this study

Summary

Sepsis is a clinical entity that complicates infection. Without early recognition and timely management, it can rapidly progress to severe sepsis, septic shock, and culminate in multiple organ dysfunction syndrome. Forty to 70% of septic patients have low vitamin D status, yet little is known about the impact of vitamin D3 (vitD3) supplementation in this patient population. As such, the investigators propose a randomized, double-blinded, placebo-controlled trial to test the hypothesis that early, rapid correction of low vitamin D status, as an adjunct to established treatment guidelines, will improve clinical outcomes and measurably alter immune profile in patients with severe sepsis.

Conditions

  • Sepsis
  • Severe Sepsis
  • End Organ Damage
  • Multi Organ Failure

Interventions

DRUG

vitamin D3

Patients will be given 400,000 IU of vitamin D3 within 24 hours of severe sepsis onset followed by weekly doses of 25,000 IU until 90 days or death, whichever comes first.

DRUG

Placebo

Patients will be given placebo within 24 hours of severe sepsis onset followed by weekly doses of placebo until 90 days or death, whichever comes first.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Sadeq A Quraishi, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2022-07-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02684487 on ClinicalTrials.gov