Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

There are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. 240 patients with low calcidiol levels will be enrolled and be provided varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18-year-old critically ill patient.

• ICU admission \< 24 hours.

• Baseline 25(OH)D levels within 24 hours of ICU admission \< 20 ng/mL.

• Expected ICU length of stay ≥ 72 hours.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Yin Yi Han, doctor
noviahan@gmail.com
886972651405
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 240
Treatments
Placebo_comparator: Control1
Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving 40 cc. medium-chain triglyceride (MCT) supplement.
Placebo_comparator: Control2
Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving 50 cc. MCT supplement.
Placebo_comparator: Control3
Participants with serum 25(OH)D levels below 12 ng/mL, receiving 60 cc. MCT supplement.
Experimental: Vitamin D1
Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving vitamin D3 of 576,000 IU supplement
Experimental: Vitamin D2
Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving vitamin D3 of 720,000 IU supplement
Experimental: Vitamin D3
Participants with serum 25(OH)D levels below 12 ng/mL, receiving vitamin D3 of 864,000 IU supplement
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov