Abnormally High Parathyroid Hormone Levels Worsens Outcomes in Vitamin D Depleted Critical Care Patients

NCT06711874 | Active Not Recruiting

• 1 other identifier: 202404064RINA
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the impacts of abnormally elevated PTH levels on clinical outcomes among critically ill patients with vitamin D depletion.

Conditions

Vitamin D Deficiency; Hyperparathyroidism; Critically Ill Patients Admitted in ICU

Keywords

parathyroid hormone; vitamin D depletion; 25(OH)D; critical illness; mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  Survival on day 28, survival to hospital discharge

  From enrollment to day 90

Secondary Outcomes (4)

• Acute Physiology and Chronic Health Evaluation II (APACHE II) score

  From enrollment to day 90

• Sequential Organ Failure Assessment (SOFA) score

  From enrollment to day 90

• ICU length of stay

  From enrollment to day 90

• Laboratory parameters

  From enrollment to day 90

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patient

You may qualify if:

• \. Critically ill patients within 48 hours of ICU admission

You may not qualify if:

• Less than 20 years old
• Severe malnutrition (BMI\<18kg/m2)
• Severe anemia (hemoglobin concentration \<7g/dL)
• Receiving high-dose vitamin D treatment (\> 3000 IU/day) within four weeks
• Have been admitted to the ICU within three months
• Suffering from diseases that affect vitamin D concentration, calcium metabolism or bone metabolism (for example: parathyroid disease, rickets, chirtosis, and severe cirrhosis \[Child C\])
• Patients and family members who do not speak the native language

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Hyperparathyroidism; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 2, 2024
• Study Start: May 21, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)