Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis

Launched by CHIMEI MEDICAL CENTER · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a high dose of vitamin D3 (cholecalciferol) on critically ill patients with sepsis, a serious condition caused by infection. The goal is to see if giving patients 576,000 IU of vitamin D3 can improve their health outcomes while they are in the intensive care unit (ICU). Researchers believe that vitamin D3 might help reduce inflammation and improve organ function, which are critical for recovery. In this study, 240 participants will receive either the vitamin D3 supplement or a placebo (a substance with no active effect) for three days, within the first four days of their ICU stay.

To be eligible for this trial, participants must be at least 18 years old, diagnosed with sepsis, and expected to stay in the ICU for at least seven days. They should also have certain health indicators, like a specific severity score, that show they are critically ill. However, people with certain health conditions or those who have recently taken high doses of vitamin D3 cannot participate. If someone joins the trial, they will receive the treatment or placebo for three days, and the researchers will monitor their health closely. This study may help find better ways to treat critically ill patients with sepsis in the future.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Medical subject ≥ 18 years old and diagnosed with sepsis
• • 2. Transferred to the intensive care unit within 24 hours after being diagnosed with sepsis
• • 3. Admitted to the ICU with 40 \> APACHE II score ≥ 15.
• • 4. The intensivist anticipates that the subject will stay in the ICU ≥ 7 days.
• Exclusion Criteria:
• • 1. Diseases that affect serum levels of 25(OH)D and calcium, including thyroidectomy, parathyroid disease, rickets, or severe cirrhosis \[Child C\]
• • 2. Received large doses of vitamin D3 in the past four weeks (\> 2000 IU per day or ≥ 10,000 IU in a single dose)
• • 3. Admitted to the ICU with diagnosis of COVID-19
• • 4. AIDS subjects taking immunosuppressants
• • 5. Organ transplant
• • 6. Active cancer
• • 7. Tuberculosis, sarcoidosis, or kidney stones in the past one year
• • 8. Weight \< 45 kg or \> 90 kg
• • 9. Had been admitted to ICU in the past three months
• • 10. Subject and family members who do not speak the native language
• • 11. Pregnant women