Correction of vitamin D deficiency in critically ill patients: a randomized, doulbe-blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018798-39-AT

Enrollment

480

Registered

2010-03-29

Start date

2010-05-03

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill patients with vitamin D deficiency

Interventions

Trade Name: Oleovit D3 Product Name: Oleovit D3 Pharmaceutical Form: Oral drops* INN or Proposed INN: CHOLECALCIFEROL CAS Number: 67-97-0 Concentration unit: ml millilitre(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - Expected ICU stay = 48 hours - Vitamin D deficiency: 25(OH)D = 20ng/ml - Feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Moribund patient expected to die within 24 hours - Hypercalcaemia (toal calcium > 2.65 or ionised calcium > 1,35mmol/L) - Severly impaired gastrointestinal motility (ileus, gastric residual volume > 400ml) - pregnancy - Known history of recent nephrolithiasis (= 1 year) -Known granulomatous diseases (tuberculosis, sarcoidosis)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to investigate whether oral high-dose of vitamin D-supplementation leads to a significant reduction of the duration of hospital stay;Secondary Objective: - Percentage of patients with 25(OH)D = 30ng/ml at day 7 - ICU stay (in hours) - Duration of mechanical ventilation (days) - Cardiac function (NT-proBNP levels, days on catecholamine support) - Frequency and length of periods with elevated CRP- and PCT-levels (area under the CRP- and PCT-curve) - TISS 28 and SAPS II scores during ICU stay - Overall mortality in hospital, at day 28 and at 6 months - Serum-calcium, serum-phosphorus, 25(OH)D, 1,25(OH)D, PTH, Osteocalcin, bALP, TRAP, urinary calcium at days 0,3,7 and 28 (if patient is still hospitalised) ;Primary end point(s): duration of hospital stay	—

Measure

Time frame

Main Objective: The primary objective of this study is to investigate whether oral high-dose of vitamin D-supplementation leads to a significant reduction of the duration of hospital stay;Secondary Objective: - Percentage of patients with 25(OH)D = 30ng/ml at day 7 - ICU stay (in hours) - Duration of mechanical ventilation (days) - Cardiac function (NT-proBNP levels, days on catecholamine support) - Frequency and length of periods with elevated CRP- and PCT-levels (area under the CRP- and PCT-curve) - TISS 28 and SAPS II scores during ICU stay - Overall mortality in hospital, at day 28 and at 6 months - Serum-calcium, serum-phosphorus, 25(OH)D, 1,25(OH)D, PTH, Osteocalcin, bALP, TRAP, urinary calcium at days 0,3,7 and 28 (if patient is still hospitalised) ;Primary end point(s): duration of hospital stay

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026