Vitamin D DeficiencyNCT06366776
Emulated Study of Vitamin D Correction Vs Non-Correction
An observational study of Vitamin D Deficiency, run by The Cooper Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 9,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- total billed costs for any reason;
- total billed costs for hospitalizations;
- total billed costs for ICU admissions;
- total billed costs for emergency room visits;
- total billed costs for all other outpatient services;
- total billed costs for urgent care visits;
- total billed costs for primary care physician (PCP) services;
- total billed costs for nurse practitioner (NP) services;
- total billed costs for all other professional services;
- total billed costs for medical pharmacy services and products.
The parameters are:
- number of hospitalizations for any reason;
- number of ICU admissions for any reason;
- number of emergency room visits for any reason;
- all other outpatient services for any reason;
- number of urgent care visits for any reason;
- number of primary care physician visits for any reason;
- number of nurse practitioner visits for any reason;
- all other professional services for any reason;
- number of medical pharmacy services for any reason;
- 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.
- 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
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 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.
Measured: 3 year observation period
Secondary outcomes (2)
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).
Measured: 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).
Measured: 3 year observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start14 Aug 2024
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Won Sook Chung Foundation
- Responsible party
- Sponsor
- Investigators
- Ludmil Mitrev, MD, Principal investigator, Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366776
- Sponsor's protocol ID
- 23-278
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emulated Clinical Trial of the Influence of Corrected Low 25-OH Vitamin D Levels on Healthcare Costs and Healthcare Utilization
- ClinicalTrials.gov ID
- NCT06366776
- Acronym / sponsor ID
- 23-278
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, healthcare cost, healthcare utilization, hospitalization, emergency room visit, intensive care unit admission, emulated trial, target trial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Collaborators
- Won Sook Chung Foundation
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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:
- total billed costs for any reason;
- total billed costs for hospitalizations;
- total billed costs for ICU admissions;
- total billed costs for emergency room visits;
- total billed costs for all other outpatient services;
- total billed costs for urgent care visits;
- total billed costs for primary care physician (PCP) services;
- total billed costs for nurse practitioner (NP) services;
- total billed costs for all other professional services;
- total billed costs for medical pharmacy services and products.
The parameters are:
- number of hospitalizations for any reason;
- number of ICU admissions for any reason;
- number of emergency room visits for any reason;
- all other outpatient services for any reason;
- number of urgent care visits for any reason;
- number of primary care physician visits for any reason;
- number of nurse practitioner visits for any reason;
- all other professional services for any reason;
- number of medical pharmacy services for any reason;
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A.
Time frame: 3 year observation period
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..
Ten healthcare utilization parameters among the corrected Treatment Group and the uncorrected Control Group A.
Time frame: 3 year observation period
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.
2 secondary outcomes
Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B).
Time frame: 3 year observation period
Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B).
Time frame: 3 year observation period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludmil Mitrev, MD principal investigator
Cooper Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by The Cooper Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A. (time frame: 3 year observation period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.