NCT01130181

Brief Summary

Study hypothesis: High-dose vitamin D leads to a shorter hospital stay in critically ill patients Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

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

May 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

May 21, 2010

Last Update Submit

May 23, 2014

Conditions

Critical IllnessVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted.

    maximum 6 months

Secondary Outcomes (5)

  • 25(OH)D levels

    maximum 6 months

  • calcium levels

    maximum 6 months

  • length of ICU stay starting from application of study medication

    until patient's death or referral to another ward

  • duration of mechanical ventilation

    starting from application of study medication

  • hospital mortality, 28-day mortality, 6 month-mortality

    maximum 6 months

Study Arms (2)

Cholecalciferol

EXPERIMENTAL
Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CholecalciferolDRUG

loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU

Cholecalciferol
PlaceboDRUG

Matching placebo

Also known as: herbal oil
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • expected ICU stay ≥48 hours
  • vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
  • feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

You may not qualify if:

  • moribund patient expected to die within 24 hours
  • hypercalcaemia (total calcium \>2.65 OR ion. calcium \>1.35 mmol/l)
  • severely impaired gastrointestinal motility (ileus, residual gastric volume \> 400 ml)
  • known history of recent kidney stones (≤ 1 year)
  • known granulomatous diseases (tuberculosis, sarcoidosis)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (11)

  • Lee P, Eisman JA, Center JR. Vitamin D deficiency in critically ill patients. N Engl J Med. 2009 Apr 30;360(18):1912-4. doi: 10.1056/NEJMc0809996. No abstract available.

    PMID: 19403914BACKGROUND

  • Lucidarme O, Messai E, Mazzoni T, Arcade M, du Cheyron D. Incidence and risk factors of vitamin D deficiency in critically ill patients: results from a prospective observational study. Intensive Care Med. 2010 Sep;36(9):1609-11. doi: 10.1007/s00134-010-1875-8. Epub 2010 Apr 7. No abstract available.

    PMID: 20373095BACKGROUND

  • Lee P, Nair P, Eisman JA, Center JR. Vitamin D deficiency in the intensive care unit: an invisible accomplice to morbidity and mortality? Intensive Care Med. 2009 Dec;35(12):2028-32. doi: 10.1007/s00134-009-1642-x. Epub 2009 Sep 15.

    PMID: 19756497BACKGROUND

  • Mata-Granados JM, Vargas-Vasserot J, Ferreiro-Vera C, Luque de Castro MD, Pavon RG, Quesada Gomez JM. Evaluation of vitamin D endocrine system (VDES) status and response to treatment of patients in intensive care units (ICUs) using an on-line SPE-LC-MS/MS method. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):452-5. doi: 10.1016/j.jsbmb.2010.03.078. Epub 2010 Apr 21.

    PMID: 20399267BACKGROUND

  • Krishnan A, Ochola J, Mundy J, Jones M, Kruger P, Duncan E, Venkatesh B. Acute fluid shifts influence the assessment of serum vitamin D status in critically ill patients. Crit Care. 2010;14(6):R216. doi: 10.1186/cc9341. Epub 2010 Nov 26.

    PMID: 21110839BACKGROUND

  • Amrein K, Venkatesh B. Vitamin D and the critically ill patient. Curr Opin Clin Nutr Metab Care. 2012 Mar;15(2):188-93. doi: 10.1097/MCO.0b013e32834f0027.

    PMID: 22186356BACKGROUND

  • Braun AB, Gibbons FK, Litonjua AA, Giovannucci E, Christopher KB. Low serum 25-hydroxyvitamin D at critical care initiation is associated with increased mortality. Crit Care Med. 2012 Jan;40(1):63-72. doi: 10.1097/CCM.0b013e31822d74f3.

    PMID: 21926604BACKGROUND

  • Amrein K, Schnedl C, Berghold A, Pieber TR, Dobnig H. Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial. BMC Endocr Disord. 2012 Nov 7;12:27. doi: 10.1186/1472-6823-12-27.

    PMID: 23134762BACKGROUND

  • Amrein K, Zajic P, Schnedl C, Waltensdorfer A, Fruhwald S, Holl A, Purkart T, Wunsch G, Valentin T, Grisold A, Stojakovic T, Amrein S, Pieber TR, Dobnig H. Vitamin D status and its association with season, hospital and sepsis mortality in critical illness. Crit Care. 2014 Mar 24;18(2):R47. doi: 10.1186/cc13790.

    PMID: 24661739BACKGROUND

  • Schwetz V, Schnedl C, Urbanic-Purkart T, Trummer C, Dimai HP, Fahrleitner-Pammer A, Putz-Bankuti C, Christopher KB, Obermayer-Pietsch B, Pieber TR, Dobnig H, Amrein K. Effect of vitamin D3 on bone turnover markers in critical illness: post hoc analysis from the VITdAL-ICU study. Osteoporos Int. 2017 Dec;28(12):3347-3354. doi: 10.1007/s00198-017-4190-1. Epub 2017 Aug 25.

    PMID: 28842727DERIVED

  • 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: 25268295DERIVED

MeSH Terms

Conditions

Critical IllnessVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Harald Dobnig, MD

    Medical University of Graz, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 25, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

AU(1)