Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 11 for:    sepsis | "vitamin d"

Vitamin D Status in Patients With Severe Sepsis (ViDISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02684487
Recruitment Status : Not yet recruiting
First Posted : February 18, 2016
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Sadeq A. Quraishi, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Sepsis Severe Sepsis End Organ Damage Multi Organ Failure Drug: vitamin D3 Drug: Placebo Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Status in Patients With Severe Sepsis: A Randomized Clinical Trial
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin D

Arm Intervention/treatment
Active Comparator: vitamin D3
Patients will be given single dose of vitamin D3 within 24 hours of new-onset severe sepsis, followed by weekly doses of vitD3 (25,000 IU) up to 90 days to assess clinical outcomes and key biomarkers.
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.
Other Name: cholecalciferol

Sham Comparator: Placebo
Patients will be given placebo intervention within 24 hours of new onset severe sepsis followed by or placebo for up to 90 days to assess clinical outcomes and key biomarkers.
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.
Other Name: sugar pill, sham comparator




Primary Outcome Measures :
  1. 90 day mortality [ Time Frame: 90 day mortality ]
    90 day mortality will be assessed in patients included in the study


Secondary Outcome Measures :
  1. Serum b25OHD: Baseline serum b25OHD and serum b25OHD after intervention, until hospital day 5 [ Time Frame: 24h of severe sepsis onset until hospital day 5 ]
    b25 OHD will be measured in the first 5 days after the onset of severe sepsis

  2. Serum measurement of AMPs, cathelicidin, and B-defensin: Baseline serum AMPs, cathelicidin, and B-defensin and AMPs, cathelicidin, and B-defensin after intervention, until hospital day 5 [ Time Frame: 24h of severe sepsis onset until hospital day 5 ]
    AMPs, Cathelicidin and B-defensin will be measured in the first 5 days after the onset of severe sepsis

  3. Serum measurement of cytokines: Baseline serum cytokines and serum cytokines after intervention, until hospital day 5 [ Time Frame: 24h of severe sepsis onset until hospital day 5 ]
    IL1B, IL-6, IL-10 and IFN-y will be measured in the first 5 days after the onset of severe sepsis

  4. sequential organ failure assessment scores in the first 5 day after severe sepsis onset [ Time Frame: 24h of severe sepsis onset until hospital day 5 ]
    SOFA scores will be taken within the first 5 days of onset of severe sepsis in patients enrolled



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 to <80 years
  • Admitted to 1 of 4 participating ICUs
  • Meet criteria for new-onset severe sepsis* within past 12 hours

Exclusion Criteria:

  • Age ≥80 years
  • Not anticipated to survive ≥48 hours
  • Inability to obtain informed consent from patient/suitable proxy within 22 hours of new-onset severe sepsis
  • Comfort measures, hospice, or palliative care status
  • Documented adverse reaction to vitamin D supplementation
  • Inability to tolerate enteral feeds/medications
  • Renal stones within past year
  • Hypercalcemia within past year
  • Baseline serum calcium ≥10.5 mg/dL
  • Established diagnosis of medical condition associated with high risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684487


Contacts
Layout table for location contacts
Contact: Sadeq A Quraishi, MD 617-643-5430 SQURAISHI@mgh.harvard.edu
Contact: Tiffany M Otero, BS 617-643-5430 totero@partners.org

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Sadeq A. Quraishi, MD    617-643-5430    squraishi@partners.org   
Contact: Tiffany M Otero, BS    617-643-5430    totero@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sadeq A Quraishi, MD Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Sadeq A. Quraishi, Critical Care Intensivist, Assistant Professor of Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02684487     History of Changes
Other Study ID Numbers: ViDISS_temp
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sadeq A. Quraishi, Massachusetts General Hospital:
vitamin D
vitamin D3
sepsis
severe sepsis
critical illness
ICU
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Vitamin D
Multiple Organ Failure
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents