- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03739671
Vitamin D Supplementation and Effects on Mood in Emergency Medicine Residents
November 26, 2024 updated by: Spectrum Health - Lakeland
Correlation of Vitamin D Supplementation in Emergency Medicine Residents and Seasonal Mood Symptoms
Seasonal mood changes, and even feelings of depression, appear to have an association with decreased amounts of vitamin D in people living in geographic areas where exposure to sunlight during the winter months is relatively low.
In this study, PGY-2 and PGY-3 Emergency Medicine residents at Lakeland Health will fill out PHQ-9 surveys for a total of 6 months (October-March), filled out at the end of each month.
This is the time of year in southwest Michigan where exposure to direct sunlight is the lowest.
The results of the individual surveys will be trended for the entire six months to see if individuals responds more positively after Vitamin D supplementation is initiated between months 3 and 4. Vitamin D supplementation will be 5000 units daily for the months of January-March.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Saint Joseph, Michigan, United States, 49085
- Lakeland Regional Healthcare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- PGY-2 and PGY-3 Emergency Medicine Residents at Lakeland Health
Exclusion Criteria:
- Nonresidents and PGY-1 and PGY-4 Emergency Medicine residents at Lakeland Health
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Non-vitamin D supplementation
Group not receiving vitamin D supplementation
|
No vitamin D supplementation
|
|
Experimental: Vitamin D supplementation
Group receiving vitamin D supplementation
|
Group will receive 5000 units of vitamin D daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of vitamin D on resident mood
Time Frame: 6 months
|
Using the Patient Health Questionnaire 9 (PHQ-9) survey results, data will be analyzed to determine if vitamin D helped increase positive responses as it correlates to mood.
Using the Patient Health Questionnaire - 9 to determine the severity of the depressive moods.
(Scaled from 0-27 with higher numbers being more severe.
0-4 is minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 9, 2018
First Posted (Actual)
November 14, 2018
Study Record Updates
Last Update Posted (Actual)
November 29, 2024
Last Update Submitted That Met QC Criteria
November 26, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMMC#1580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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