Emulated Study of Vitamin D Correction Vs Non-Correction

Emulated Clinical Trial of the Influence of Corrected Low 25-OH Vitamin D Levels on Healthcare Costs and Healthcare Utilization

• 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitamin D Deficiency

Detailed Description

• The purpose of the study is to characterize healthcare costs and healthcare utilization in subjects with corrected low (<40 ng/ml) 25-OH vitamin D levels compared to subjects with uncorrected low 25-OH vitamin D levels during a three-year period.
• The primary objective of this study is to determine whether ten healthcare costs are lower and ten healthcare utilization parameters occur less frequently in patients with corrected low vitamin D levels compared to patients with uncorrected low vitamin D levels in Cooper outpatients and inpatients.

The costs are:

1. total billed costs for any reason;
2. total billed costs for hospitalizations;
3. total billed costs for ICU admissions;
4. total billed costs for emergency room visits;
5. total billed costs for all other outpatient services;
6. total billed costs for urgent care visits;
7. total billed costs for primary care physician (PCP) services;
8. total billed costs for nurse practitioner (NP) services;
9. total billed costs for all other professional services;
10. total billed costs for medical pharmacy services and products.

The parameters are:

1. number of hospitalizations for any reason;
2. number of ICU admissions for any reason;
3. number of emergency room visits for any reason;
4. all other outpatient services for any reason;
5. number of urgent care visits for any reason;
6. number of primary care physician visits for any reason;
7. number of nurse practitioner visits for any reason;
8. all other professional services for any reason;
9. number of medical pharmacy services for any reason;

10. number of free-standing prescriptions for any reason.

    • The secondary objective is to determine the effect of sufficient vitamin D levels (≥ 40 ng/ml) in subjects not requiring a prior correction on the ten healthcare costs parameters and the ten healthcare utilization parameters listed in the primary objective above.

• Study Type: Observational
• Enrollment (Actual): 9000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B).	The secondary outcomes are the ten healthcare costs parameters listed in the primary outcomes above relating to patients with sufficient vitamin D levels who did not require a prior correction (Control Group B).	3 year observation period
Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B).	The secondary outcomes are the ten healthcare utilization parameters listed in the primary outcomes above relating to patients with sufficient vitamin D levels who did not require a prior correction (Control Group B).	3 year observation period

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Collaborators: Won Sook Chung Foundation
• Investigators: Principal Investigator: Ludmil Mitrev, MD, Cooper Health System

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 18, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: vitamin D; hospitalization; multimorbidity; real world data; healthcare utilization; healthcare cost; propensity score; emergency room visit; intensive care unit admission; emulated trial; target trial; combined comorbidity
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: 23-278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No