Emulated Study of Vitamin D Correction Vs Non-Correction

NCT06366776 | Active Not Recruiting

• 1 other identifier: 23-278
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

Brief Summary

• This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database.
• The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels.

Conditions

Vitamin D Deficiency

Keywords

vitamin D; healthcare cost; healthcare utilization; hospitalization; emergency room visit; intensive care unit admission; emulated trial; target trial; real world data; combined comorbidity; multimorbidity; propensity score

Outcome Measures

Primary Outcomes (2)

• Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A.

  The ten healthcare costs parameters: total billed costs for any reason; costs for hospitalizations; costs for ICU admissions; costs for emergency room visits; costs for all other outpatient services; costs for urgent care visits; costs for primary care physician (PCP) services; costs for nurse practitioner (NP) services; costs for all other professional services; and costs for medical pharmacy services and products among Treatment Group and Control Group A..

  3 year observation period

• Ten healthcare utilization parameters among the corrected Treatment Group and the uncorrected Control Group A.

  The ten healthcare utilization parameters: number of hospitalizations; number of ICU admissions; number of emergency room visits; all other outpatient services; number of urgent care visits; number of primary care physician services; number of nurse practitioner services; all other professional services; number of medical pharmacy services or products; and number of free-standing prescriptions among Treatment Group and Control Group A.

  3 year observation period

Secondary Outcomes (2)

• Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B).

  3 year observation period

• Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B).

  3 year observation period

Study Arms (3)

Treatment Group

Any patient with a 25-OH vitamin D level(s) always lower than 40 ng/ml (low level) with subsequent level(s) in the 40 ng/ml to 100 ng/ml range. The 40 ng/ml to 100 ng/ml range is maintained for three years.

Control Group A

Any patient with a 25-OH vitamin D level always lower than 40 ng/ml with maintenance of that lower than 40 ng/ml level for 3 years.

Control Group B

Any patient who has an uninterrupted 25-OH vitamin D level greater than or equal 40 ng/ml and less than or equal to 100 ng/ml (sufficient level) for a continuous 3-year period. Prior to the 3-year period there were no levels lower than 40ng/ml or higher than 100 ng/ml.

Eligibility Criteria

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

Study Population

The investigators anticipate reviewing records from thousands of patients in order to identify enough patients that meet the eligibility criteria. Investigators will enroll at a minimum 3,000 patients in the Treatment Group and at a minimum 3,000 patients in Control Group A regarding the primary objective. In regard to the secondary objective, the investigators will enroll as many as available for Control Group B.

You may qualify if:

• Any patient with at least one 25-OH vitamin D test result. Patients with one test result will remain in the limited dataset for potential future research.
• Any patient with a 25-OH vitamin D level(s) always lower than 40 ng/ml (low level) with subsequent level(s) in the 40 ng/ml to 100 ng/ml range. The 40 ng/ml to 100 ng/ml range is maintained for three years. This corrected group is labeled as the Treatment Group.
• Any patient with a 25-OH vitamin D level always lower than 40 ng/ml with maintenance of that lower than 40 ng/ml level for 3 years. This uncorrected group is labeled as Control Group A.
• Any patient who has an uninterrupted 25-OH vitamin D level greater than or equal 40 ng/ml and less than or equal to 100 ng/ml (sufficient level) for a continuous 3-year period. Prior to the 3-year period there were no levels lower than 40ng/ml or higher than 100 ng/ml. This vitamin D3 sufficient group is labeled as Control Group B.

You may not qualify if:

• Any patient with only one 25-OH vitamin D3 test result or any patient who cannot be included in the Treatment Group, Control Group A, or Control Group B is excluded.

Sponsors & Collaborators

• The Cooper Health System: lead
• Won Sook Chung Foundation: collaborator

Study Sites (1)

Cooper Health System

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ludmil Mitrev, MD

  Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 16, 2024
• Study Start: August 14, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)