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Vitamin Supplement

Rapid Vitamin D Supplementation for Vitamin D Deficiency (VITdALIZE-KIDS Trial)

Phase 3

Recruiting

Led By Dayre McNally, MD, PhD

Research Sponsored by Children's Hospital of Eastern Ontario

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Corrected gestational age 37 weeks to age 18 years

Admitted to PICU

Must not have

Severe liver failure

Known nephrolithiasis or nephrocalcinosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrolment and on >48 hours following enrollment (range: day 2-7)

Awards & highlights

Pivotal Trial

Summary

This trial will determine whether rapidly restoring vitamin D levels in critically ill children who are deficient improves survival and health-related quality of life.

Who is the study for?

This trial is for critically ill children in Canadian PICUs, aged from 37 weeks corrected gestational age to 18 years old, who have a confirmed vitamin D deficiency. It's not suitable for those expected to leave the PICU within three days of enrollment or with certain medical conditions like severe liver failure, hypercalcemia, or allergies to vitamin D.

What is being tested?

The study tests if high-dose Vitamin D3 (cholecalciferol) can improve survival and quality of life in vitamin D deficient critically ill children compared to a placebo. Participants will receive either one dose of Vitamin D3 up to 400,000 IU or no drug and be monitored for health changes over 90 days.

What are the potential side effects?

In a previous pilot trial using the same high-dose Vitamin D3 regimen, no serious side effects were reported. However, potential risks may include elevated calcium levels which could lead to kidney stones or other related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 37 weeks of corrected gestational age and 18 years old.

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I am currently admitted to the Pediatric Intensive Care Unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver failure.

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I have been diagnosed with kidney stones or kidney calcification.

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I have been diagnosed with or suspected to have William's syndrome.

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I am not planning to stop or change my current treatment for another ICU not in the VITdALIZE-KIDS trial.

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I am a young woman who can have children and I am pregnant.

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I am currently taking digoxin.

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I am taking more calcium than recommended while on water pills.

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My doctor won't give me drugs by mouth due to a stomach issue for my entire PICU stay.

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I have been diagnosed with tuberculosis or sarcoidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrolment and on >48 hours following enrollment (range: day 2-7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrolment and on >48 hours following enrollment (range: day 2-7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrolment and on >48 hours following enrollment (range: day 2-7) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Health related quality of life

Secondary study objectives

New and/or progressive multiple organ dysfunction

Other study objectives

Biomarker Analysis - Anti-inflammatory cytokines

Biomarker Analysis - Bone markers

Biomarker Analysis - Brain natriuretic peptide

+11 more

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615

23%

Hypophospatemia

17%

Fatigue

13%

Increased hypertension

13%

Edema

13%

Diarrhea

13%

Pain

10%

Taste perversions

10%

Arthritis

10%

Dizziness

10%

Gastroenteritis

10%

Vertigo

10%

Rhinitis

10%

Bronchitis

10%

Rash

Viral Infection

Leg Cramps

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Paricalcitol Treatment

Calcitriol Treatment

Cholecalciferol

Supplemental

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin DExperimental Treatment1 Intervention

Approximately half of the subjects randomized into VITdALIZE-KIDS will be randomized into the Vitamin D Group and will receive a single dose of cholecalciferol at enrolment. Participants may also receive standard vitamin D dosing at the discretion of the care team (e.g. 400-1000 IU/day).

Group II: PlaceboPlacebo Group1 Intervention

Approximately half of the subjects randomized into VITdALIZE-KIDS will be randomized into the Placebo Group and will receive a single dose of placebo at enrolment. Participants may also receive standard vitamin D dosing at the discretion of the care team (e.g. 400-1000 IU/day).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cholecalciferol

2014

Completed Phase 4

~1100

0 / 11Eligibility criteria met