Rapid normalization of Vitamin D in critically ill children

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2016-002459-38-AT
• Date of registration: 19/01/2017
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital of Eastern Ontario
• Public title: Rapid normalization of Vitamin D in critically ill children
• Scientific title: Rapid normalization of Vitamin D in critically ill children: A phase II dose evaluation randomized controlled trial (VITdAL-PICU pilot) - VITdAL-PICU
• Date of first enrolment: 28/02/2017
• Target sample size: 60
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002459-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Canada, Chile

Contacts

• Name: Division of Endocrinology and D.
• Affiliation: Medical University of Graz

• Name: Division of Endocrinology and D.
• Affiliation: Medical University of Graz

Key inclusion & exclusion criteria

Inclusion criteria:
The inclusion criteria for this study are:
Admitted to ICU,
Corrected gestational age > 37 weeks to age < 18 years,
Expected ICU admission in excess of 48 hours, and will have access for bloodwork at 7 days (clinical bloodwork or lines)
Blood 25(OH)D less than 50 nmol/L (regardless of prior approach to supplementation),
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Critically ill children with severe vitamin D deficiency
MedDRA version: 19.1 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Oleovit
Pharmaceutical Form: Oral liquid
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Colecalciferol concentrate (oily form)
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 14400-
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To evaluate whether the weight based vitamin D loading protocol, when compared with usual care, results in:
1. Greater occurrence of vitamin D related adverse events (e.g. hypercalcemia, hypercalciuria)
2. Improved vitamin D axis functioning (e.g. active hormone levels, calcium metabolism)
3. Differences in blood measures of inflammation and innate immunity (e.g. CRP, procalcitonin

Timepoint(s) of evaluation of this end point: up to 2 years

Main Objective: To determine whether a weight based enteral loading dose protocol can rapidly normalize vitamin D levels in critically ill children

Primary end point(s): To determine whether loading dose therapy can rapidly normalize vitamin D status we will measure blood 25(OH)D concentration. More specifically, our primary outcome is the proportion of critically ill children who achieve blood 25(OH)D concentration above 75 nmol/L by day 7. 25(OH)D is widely regarded as the best indicator of vitamin D status

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: up to 2 years

Secondary end point(s): Vitamin D related adverse events
Hypercalcemia – We will define hypercalcemia as an ionized calcium level above 1.40 mmol/L (children under 8 weeks as > 1.45 mmol/L)
Hypercalcuria – We will identify hypercalcuria using calcium-creatinine ratios, defined using age specific norms and thresholds

Secondary ID(s)

VITdAL-PICUPilot

Source(s) of Monetary Support

Medical University of Graz