NCT03739671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

November 9, 2018

Last Update Submit

November 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months

Study Arms (2)

Non-vitamin D supplementation

PLACEBO COMPARATOR

Group not receiving vitamin D supplementation

Dietary Supplement: No Vitamin D

Vitamin D supplementation

EXPERIMENTAL

Group receiving vitamin D supplementation

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

Group will receive 5000 units of vitamin D daily

Vitamin D supplementation
No Vitamin DDIETARY_SUPPLEMENT

No vitamin D supplementation

Non-vitamin D supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PGY-2 and PGY-3 Emergency Medicine Residents at Lakeland Health

You may not qualify if:

  • Nonresidents and PGY-1 and PGY-4 Emergency Medicine residents at Lakeland Health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakeland Regional Healthcare

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Conditions

Seasonal Affective Disorder

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 14, 2018

Study Start

October 1, 2018

Primary Completion

March 30, 2020

Study Completion

April 30, 2020

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations