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Effect of 25-hydroxy vitamin D on inflammation and bone-turnover in critically ill patients

Effect of 25-hydroxy vitamin D on inflammation and bone-turnover in critically ill patients: a blinded, prospective, randomised, controlled, parallel group trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24385496
Enrollment
24
Registered
2009-04-23
Start date
2004-01-12
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Inflammation/calcium and bone metabolism Nutritional, Metabolic, Endocrine Vitamin D deficiency

Interventions

Informed consent will be requested from the next of kin (closest family member or legal guardian) before inclusion in the study. The family member or the patient can withdraw from the trial, at any ti

Sponsors

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients admitted to any of the four intensive care units with an anticipated Intensive Care Unit (ICU) stay of greater than 10 days 2. Older than 18 years, either sex

Exclusion criteria

Exclusion criteria: 1. Younger than 18 years 2. Patients suffering from chronic bone disease 3. Patients suffering from parathyroid disease 4. Patients suffering from chronic kidney disease 5. Patients known to be pregnant or nursing 6. Prior treated with glucocorticoids before ICU admission 7. Patients with a 'do not resuscitate' (DNR) code at the time of ICU admission 8. Patients already enrolled in another trial

Design outcomes

Primary

MeasureTime frame
1. Inflammation and innate immunity patterns, daily during study period (from day 0 till day 10) 2. Bone turnover and vitamin D status: via blood and urine analyses, daily during study period (from day 0 till day 10)

Secondary

MeasureTime frame
1. Infections, during ICU stay: from admission untill ICU discharge 2. Organ function: Apache (measured upon ICU admission) and Sequential Organ Failure Assessment (SOFA) (measured daily during study period [from day 0 till day 10]) scores 3. ICU stay, measured upon discharge 4. Mortality (ICU, hospital), measured during ICU stay and hospital stay

Countries

Belgium

Outcome results

None listed

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