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Completed

NCT Number: NCT01130181

VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients

Study hypothesis:

High-dose vitamin D leads to a shorter hospital stay in critically ill patients

Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.

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Key information

Conditions

Critical Illness Avitaminosis Deficiency Diseases Disease Attributes Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Graz

Graz, 8036, Austria

About this study

Inclusion criteria

  • Age ≥18 years
  • expected ICU stay ≥48 hours
  • vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
  • feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Exclusion criteria

  • moribund patient expected to die within 24 hours
  • hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
  • severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
  • known history of recent kidney stones (≤ 1 year)
  • known granulomatous diseases (tuberculosis, sarcoidosis)
  • pregnancy

Primary endpoint

  • hospital stay (hours; starting from ICU admission) Secondary endpoints
  • percentage of patients with 25(OH)D ≥ 30 ng/ml at day 7
  • serum calcium; phosphorus; 25(OH)D; 1,25(OH)D; PTH; osteocalcin; bALP; TRAP; urinary calcium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • expected ICU stay ≥48 hours
  • vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
  • feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Exclusion criteria

  • moribund patient expected to die within 24 hours
  • hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
  • severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
  • known history of recent kidney stones (≤ 1 year)
  • known granulomatous diseases (tuberculosis, sarcoidosis)
  • pregnancy

Treatment and study plan

Cholecalciferol

Drug

loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU

Placebo

Drug

Matching placebo

Other names: herbal oil

Primary outcomes

  1. Length of hospital stay

    Time frame: maximum 6 months

    The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted.

Secondary outcomes

  1. 25(OH)D levels

    Time frame: maximum 6 months

    serum 25(OH)D levels will be measured on day 0, 3 and 7

  2. calcium levels

    Time frame: maximum 6 months

    serum calcium levels will be measured on day 0, 3 and 7

  3. length of ICU stay starting from application of study medication

    Time frame: until patient's death or referral to another ward

  4. duration of mechanical ventilation

    Time frame: starting from application of study medication

    duration of mechanical ventilation including CPAP/mask ventilation

  5. hospital mortality, 28-day mortality, 6 month-mortality

    Time frame: maximum 6 months

Sponsors and collaborators

Lead sponsor

Harald Dobnig, MD

Other

Registry information

Official study title

Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")

Acronym: VITdAL@ICU

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 25, 2010
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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