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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
Spectrum Health - Lakeland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Mood Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 9, 2018
Last Updated
November 25, 2020
Sponsor
Spectrum Health - Lakeland
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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

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Vitamin D Supplementation and Effects on Mood in Emergency Medicine Residents

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