NCT04915963

Brief Summary

A randomized controlled trial is designed to investigate the safety and clinical efficacy of a mega dose of VD in patients admitted in intensive care unit (ICU). Patients will be randomly allocated to receive 400,000 IU of VD3 or placebo. They will be followed up until ICU discharge or death or the 15th day of ICU stay. Adverse events that occur during ICU stay is collected. Primary outcome is intensive care unit-acquired infection (ICU-AI), and secondary outcomes are septic shock, organ failure, and ICU-mortality. Plasma 25-hydroxyvitamin D is assessed at baseline and at the end of follow-up. Cox regression models will be applied to test how VD supplementation affects adverse outcomes while adjusting for confounders.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2016

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3.1 years

First QC Date

June 1, 2021

Last Update Submit

June 14, 2021

Conditions

Dietary SupplementsIntensive Care UnitVitamin D DeficiencyVitamin D Toxicity

Keywords

Critically illIntensive care unitVitamin D deficiencies

Outcome Measures

Primary Outcomes (1)

  • Rate of intensive care unit-acquired infection (ICU-AI)

    Infection of blood stream, lower respiratory tract, urinary tract, skin/soft tissue or gastrointestinal tract, which was not present within the first 48 hours of admission into the ICU, which occur during the ICU stay.

    15 days

Secondary Outcomes (4)

  • urinary calcium:creatinine ratio

    15 days

  • Rate of septic shock

    15 days

  • Rate of organ failure

    15 days

  • Rate of ICU-mortality

    15 days

Study Arms (2)

vitamin D group

EXPERIMENTAL

170 patients receiving a single dose of 400,000 IU of VD3 (2 vials of 200,000 IU VD3; B.O.N., BOUCHARA RECORDATI) orally or through a nasogastric tube

Dietary Supplement: Vitamin D supplementation

Placebo group

SHAM COMPARATOR

170 patients receiving distilled water (2 vials of 1 ml distilled water) orally or through a nasogastric tube

Dietary Supplement: Vitamin D supplementation

Interventions

Vitamin D supplementationDIETARY_SUPPLEMENT

Patients are randomized to receive vitamin D or placebo and followed up for 15 days at maximum to investigate the safety and clinical efficacy of the supplements

Placebo groupvitamin D group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly admitted (within 24 hours)
  • over eighteen,
  • able to receive medication orally or through nasogastric tube
  • expected to stay more than 72 hours in ICU
  • given consent

You may not qualify if:

  • lack of patient's or relatives' consent
  • expected short life or ICU stay (\<48 hours)
  • sepsis at admission
  • kidney, liver or intestinal disease
  • hypercalcemia (total calcium\>10.6 mg/dL)
  • history of a disorder associated with hypercalcemia (i.e., cancer, tuberculosis, sarcoidosis, hyperparathyroidism, nephrolithiasis)
  • treatment with immunotherapy or vitamin supplements within one year
  • pregnant or breastfeeding women
  • discharge from ICU or death within 72 hours of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

    PMID: 17634462BACKGROUND

  • Thomas MK, Lloyd-Jones DM, Thadhani RI, Shaw AC, Deraska DJ, Kitch BT, Vamvakas EC, Dick IM, Prince RL, Finkelstein JS. Hypovitaminosis D in medical inpatients. N Engl J Med. 1998 Mar 19;338(12):777-83. doi: 10.1056/NEJM199803193381201.

    PMID: 9504937BACKGROUND

  • Kvaran RB, Sigurdsson MI, Skarphedinsdottir SJ, Sigurdsson GH. Severe vitamin D deficiency is common in critically ill patients at a high northern latitude. Acta Anaesthesiol Scand. 2016 Oct;60(9):1289-96. doi: 10.1111/aas.12748. Epub 2016 Jun 12.

    PMID: 27291260BACKGROUND

  • Leaf DE, Raed A, Donnino MW, Ginde AA, Waikar SS. Randomized controlled trial of calcitriol in severe sepsis. Am J Respir Crit Care Med. 2014 Sep 1;190(5):533-41. doi: 10.1164/rccm.201405-0988OC.

    PMID: 25029202BACKGROUND

  • Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.

    PMID: 25268295BACKGROUND

  • Kempker JA, West KG, Kempker RR, Siwamogsatham O, Alvarez JA, Tangpricha V, Ziegler TR, Martin GS. Vitamin D status and the risk for hospital-acquired infections in critically ill adults: a prospective cohort study. PLoS One. 2015 Apr 7;10(4):e0122136. doi: 10.1371/journal.pone.0122136. eCollection 2015.

    PMID: 25849649BACKGROUND

  • Ala-Kokko TI, Mutt SJ, Nisula S, Koskenkari J, Liisanantti J, Ohtonen P, Poukkanen M, Laurila JJ, Pettila V, Herzig KH; FINNAKI Study Group. Vitamin D deficiency at admission is not associated with 90-day mortality in patients with severe sepsis or septic shock: Observational FINNAKI cohort study. Ann Med. 2016;48(1-2):67-75. doi: 10.3109/07853890.2015.1134807. Epub 2016 Jan 22.

    PMID: 26800186BACKGROUND

  • Quraishi SA, De Pascale G, Needleman JS, Nakazawa H, Kaneki M, Bajwa EK, Camargo CA Jr, Bhan I. Effect of Cholecalciferol Supplementation on Vitamin D Status and Cathelicidin Levels in Sepsis: A Randomized, Placebo-Controlled Trial. Crit Care Med. 2015 Sep;43(9):1928-37. doi: 10.1097/CCM.0000000000001148.

    PMID: 26086941BACKGROUND

MeSH Terms

Conditions

Vitamin D DeficiencyCritical Illness

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Moncef Feki, Professor

    Rabta University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 7, 2021

Study Start

January 20, 2016

Primary Completion

March 10, 2019

Study Completion

May 30, 2019

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share