Early Vitamin D3 Supplementation for Critically Ill Patients

NCT05937789 | Recruiting

• 1 other identifier: 202305074RIPC
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; Critical Illness

Keywords

vitamin D; calcidiol levels; critically ill

Outcome Measures

Primary Outcomes (1)

• 30-day mortality rate

  30-day mortality rate after intervention with the study samples.

  30 days

Secondary Outcomes (7)

• 30-day mortality rate of patients who survives >7 days

  30 days

• Length of ICU stay for surviving patients

  30 days

• Length of hospital stay for surviving patients

  30 days

• 30-day mortality based on serum 25(OH)D levels on day 7

  30 days

• 30-day mortality based on serum 25(OH)D levels on day 30

  30 days

Study Arms (6)

Control1

PLACEBO COMPARATOR

Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving 40 cc. medium-chain triglyceride (MCT) supplement.

Dietary Supplement: Medium Chain Triglycerides (MCT)

Control2

PLACEBO COMPARATOR

Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving 50 cc. MCT supplement.

Dietary Supplement: Medium Chain Triglycerides (MCT)

Control3

PLACEBO COMPARATOR

Participants with serum 25(OH)D levels below 12 ng/mL, receiving 60 cc. MCT supplement.

Dietary Supplement: Medium Chain Triglycerides (MCT)

Vitamin D1

EXPERIMENTAL

Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving vitamin D3 of 576,000 IU supplement

Dietary Supplement: Vitamin D3

Vitamin D2

EXPERIMENTAL

Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving vitamin D3 of 720,000 IU supplement

Dietary Supplement: Vitamin D3

Vitamin D3

EXPERIMENTAL

Participants with serum 25(OH)D levels below 12 ng/mL, receiving vitamin D3 of 864,000 IU supplement

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Dose of vitamin D3 depends on participant's serum 25(OH)D levels, with one sample bottle contains 72,000 IU of vitamin D3; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours

Vitamin D1; Vitamin D2; Vitamin D3

Medium Chain Triglycerides (MCT) DIETARY_SUPPLEMENT

Dose of MCT depends on participant's serum 25(OH)D levels, with one sample bottle contains 5 cc. of MCT; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours

Control1; Control2; Control3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• Hypercalcemia (ie. total serum calcium levels \> 2.6 mmol/L).
• Disorders affecting serum 25(OH)D levels, calcium metabolism, or bone metabolism (eg, parathyroid disease, rickets, or severe cirrhosis \[Child C\]).
• Having received high-dose vitamin D3 therapy (ie. \> 2,000 IU daily or a single dose of ≥ 10,000 IU) within the past four weeks.
• Active COVID-19 at ICU admission.
• Organ transplant.
• Having had tuberculosis, sarcoidosis or kidney stones within the past year.
• Having renal dialysis, continuous kidney replacement therapy (CKRT), acute kidney injury (AKI).
• Having ICU admission within the past three months.
• Non-native-speaking patients and their families
• Pregnant women.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Critical Illness

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Yin Yi Han, doctor

CONTACT

886972651405; noviahan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: January 22, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)