Actively Recruiting
Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients
Led by National Taiwan University Hospital · Updated on 2024-08-16
240
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Recent research shows vitamin D deficiency is common in critically ill patients, leading to longer ICU stays, higher costs, and increased risk of infections and death. This trial aims to evaluate early vitamin D3 supplementation in critically ill patients with low vitamin D levels to maintain sufficient serum calcidiol levels. Conducted across multiple centers in Taiwan, the study seeks to inform guidelines for vitamin D dosing based on deficiency severity. Participants will receive vitamin D3 or a placebo (medium-chain triglyceride supplement) based on their initial serum 25(OH)D levels. Supplement doses vary accordingly, with vitamin D3 given in high doses starting on ICU day 3, administered every 3 hours over 48 hours. Serum calcidiol and parathyroid hormone levels will be measured on Days 0, 7, 14, and 30 to monitor response. During the study, 240 critically ill patients will be closely monitored for vitamin D levels and clinical outcomes, including 30-day mortality. Additional assessments include length of ICU and hospital stay, mortality related to vitamin D levels, and correlations between vitamin D increments and body weight. This comprehensive monitoring will help determine the best vitamin D treatment strategy for critically ill patients over the 30-day period following ICU admission.
CONDITIONS
Brief Title
Early Vitamin D3 Supplementation for Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older who are critically ill
- ICU admission within the past 24 hours
- Baseline serum 25(OH)D (vitamin D) level below 20 ng/mL within 24 hours of ICU admission
- Expected ICU stay of at least 72 hours
You will not qualify if you...
- Hypercalcemia with total serum calcium levels above 2.6 mmol/L
- Disorders affecting vitamin D or calcium metabolism, such as parathyroid disease, rickets, or severe cirrhosis (Child C)
- High-dose vitamin D3 therapy (>2,000 IU daily or a single dose ≥ 10,000 IU) within the past four weeks
- Active COVID-19 infection at ICU admission
- History of organ transplant
- Tuberculosis, sarcoidosis, or kidney stones within the past year
- Receiving renal dialysis, continuous kidney replacement therapy, or acute kidney injury
- ICU admission within the past three months
- Non-native-speaking patients and their families
- Pregnant women
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 days starting ICU day 3
Participants receive vitamin D3 or placebo supplementation starting on ICU day 3 to maintain sufficient serum calcidiol levels. Supplementation is given every 3 hours over 48 hours, with dose depending on initial vitamin D levels.
Daily assessments on ICU day 0, 3, 7, 14, and 30
Duration - Up to 30 days after ICU admission
Participants are monitored for clinical outcomes, including mortality and length of ICU and hospital stay, with serum vitamin D levels measured at multiple time points up to 30 days after ICU admission.
Visits or assessments on Day 7, Day 14, and Day 30
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
Y
Yin Yi Han, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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