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Trial record 89 of 108 for:    CALCIUM CATION

Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial (VITdAL-PICU)

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ClinicalTrials.gov Identifier: NCT02452762
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
James Dayre McNally, Children's Hospital of Eastern Ontario

Brief Summary:
Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health, inflammation, innate immunity, and neuromuscular function have led to the hypothesis that deficiency might represent a modifiable risk factor for outcomes in critical illness. In recent years, dozens of adult studies have reported both high deficiency rates, and associations between lower vitamin D levels and organ dysfunction, health resource utilization, and mortality in the intensive care unit (ICU). More recently, similar observations have been made in critically ill pediatric populations. The cumulative body of basic science and clinical literature demonstrates that deficiency is common in critical illness and rapid normalization of vitamin D status could improve clinical outcomes and/or reduce health care costs. However, before conducting a phase III trial to determine whether restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen must be identified. Consequently, the investigators propose a phase II, double blind randomized controlled trial to determine a loading therapy dosing regimen that can safely and rapidly normalize vitamin D status in critically ill children.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Drug: Vitamin D3 Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Enteral Loading Arm
Vitamin D3 (cholecalciferol) - Single dose at enrolment of 10000 IU/kg of cholecalciferol (max 400000 IU)
Drug: Vitamin D3
Other Name: Cholecalciferol

Placebo Comparator: Placebo Arm
Patients will receive a placebo solution equivalent in volume to the dose of cholecalciferol administered to patients in the enteral loading arm.
Drug: Placebo



Primary Outcome Measures :
  1. Vitamin D Status [ Time Frame: 7 days ]
    The proportion of critically ill children who achieve a blood 25OHD concentration above 75 nmol/L by day 7


Secondary Outcome Measures :
  1. Feasibility [ Time Frame: 2 years ]
    The investigators will determine the feasibility of a subsequent multicentre phase III interventional study through an evaluation of patient accrual rate. The expected patient accrual rate is 88 patients over a 2-year period (2-5 patients per month per centre; low estimate 60 patients (0-2 per month per centre). The study will be considered feasible if the patient accrual rate is achieved

  2. Vitamin D Related Adverse Events [ Time Frame: On days 1, 2, 3, 7, hospital discharge (expected average of 2 weeks) ]
    A measurable difference in clinically significant adverse events between the loading dose and placebo arms in unlikely in a phase II study. Therefore, the investigators will evaluate for potential toxicity using two well accepted surrogate outcome measures: (1) Hypercalcemia - The investigators will define hypercalcemia as an ionized calcium level above 1.40 mmol/L (children under 8 weeks as > 1.45 mmol/l); and (2) Hypercalciuria - Hypercalciuria will be defined as an elevated calcium:creatinine ratio above age-based normal values

  3. Vitamin D Axis Function - Calcium [ Time Frame: On day 3, 7, hospital discharge (expected average of 2 weeks) ]
    Improved signalling through the vitamin D axis will be evaluated through an evaluation of blood calcium levels (i.e. calcium metabolism). Calcium levels will be reported as median plus interquartile range and will be compared between the 2 study groups.

  4. Vitamin D Axis Function - 1,25 OHD [ Time Frame: On day 3, 7, hospital discharge (expected average of 2 weeks) ]
    Improved signalling through the vitamin D axis will be evaluated through an evaluation of blood 1,25OHD levels. 1,25 levels will be reported as median plus interquartile range and will be compared between the 2 study groups.

  5. Immune Function - Cathelicidin [ Time Frame: On day 3, 7, hospital discharge (expected average of 2 weeks) ]
    Immune function will be evaluated through an evaluation of blood cathelicidin levels. Cathelicidin levels will be reported as median plus interquartile range and will be compared between the 2 study groups.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(i) Admitted to ICU; (ii) Corrected gestational age > 37 weeks to age < 18 years; (iii) Expected ICU admission in excess of 48 hours and expected access for blood work at Day 7 of hospital admission; (iv) Blood 25OHD less than 50 nmol/L (regardless of prior approach to supplementation)

Exclusion Criteria:

(i) Significant gastrointestinal disorder preventing enteral drug administration (e.g. necrotizing enterocolitis); (ii) Hypercalcemia (excluding transient abnormalities and those related to parenteral calcium administration for hypocalcemia); (iii) Confirmed or suspected William's syndrome; (iv) Patient known to have nephrolithiasis or Nephrocalcinosis; (v) Imminent plan for withdrawal of care or transfer to another ICU; (vi) Physician refusal; (vii) Previous enrollment in the study; (viii) Patient known to have granulomatous disease (tuberculosis or sarcoidosis), (ix) Severe liver dysfunction/liver failure; (x) Patient know to have hypersensitivity or allergy to vitamin D or any of the non-medicinal ingredients of the formulation; (xi) Patient on thiazide diuretics who is also receiving regular ongoing calcium supplementation above the daily recommended intake (for reasons other than hypocalcemia); (xii) Adolescent female of child-bearing age with a positive serum pregnancy test; or (xiii) Patient on digoxin-therapy


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): NCT02452762


Locations
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Austria
Medical University of Graz
Graz, Austria, 8036
Canada, Ontario
Division of Critical Care, Department of Pediatrics, Victoria Hospital
London, Ontario, Canada, N6C 3T6
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Chile
Hospital Guillermo Grant Benavente
Concepcion, Chile
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
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Principal Investigator: James D McNally Children's Hospital of Eastern Ontario
Study Chair: Menon Kusum Children's Hospital of Eastern Ontario
Study Chair: McIntyre Lauralyn The Ottawa Hospital
Study Chair: Fergusson Dean The Ottawa Hospital
Study Chair: Amrein Karin Medical University of Graz

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Dayre McNally, Pediatric Intensivist, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02452762     History of Changes
Other Study ID Numbers: VITdAL-PICU-01
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Calcium Metabolism Disorders
Calcium-Regulating Hormones and Agents
Rickets
Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents