Vitamin D Supplementation and Effects on Mood in Emergency Medicine Residents
Primary Purpose
Seasonal Mood Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
No Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Mood Disorder
Eligibility Criteria
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
Sites / Locations
- Lakeland Regional Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Non-vitamin D supplementation
Vitamin D supplementation
Arm Description
Group not receiving vitamin D supplementation
Group receiving vitamin D supplementation
Outcomes
Primary Outcome Measures
Effect of vitamin D on resident mood
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03739671
First Posted
November 9, 2018
Last Updated
November 25, 2020
Sponsor
Spectrum Health - Lakeland
1. Study Identification
Unique Protocol Identification Number
NCT03739671
Brief Title
Vitamin D Supplementation and Effects on Mood in Emergency Medicine Residents
Official Title
Correlation of Vitamin D Supplementation in Emergency Medicine Residents and Seasonal Mood Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health - Lakeland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Mood Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-vitamin D supplementation
Arm Type
Placebo Comparator
Arm Description
Group not receiving vitamin D supplementation
Arm Title
Vitamin D supplementation
Arm Type
Experimental
Arm Description
Group receiving vitamin D supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Group will receive 5000 units of vitamin D daily
Intervention Type
Dietary Supplement
Intervention Name(s)
No Vitamin D
Intervention Description
No vitamin D supplementation
Primary Outcome Measure Information:
Title
Effect of vitamin D on resident mood
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lakeland Regional Healthcare
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vitamin D Supplementation and Effects on Mood in Emergency Medicine Residents
We'll reach out to this number within 24 hrs