Seasonal Mood DisorderNCT03739671
Vitamin D Supplementation and Effects on Mood in Emergency Medicine Residents
A study testing Vitamin D and No Vitamin D in people with Seasonal Mood Disorder, run by Corewell Health South at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Mood Disorder
- What is being tested?
- Vitamin D and No Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Apr 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PGY-2 and PGY-3 Emergency Medicine Residents at Lakeland Health
Who cannot join
- Nonresidents and PGY-1 and PGY-4 Emergency Medicine residents at Lakeland Health
Trial locations and contacts
1 site in 1 country.
United States1 site
Lakeland Regional Healthcare
Saint Joseph, Michigan, 49085
About this study
Official title: 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.
- Conditions
- Seasonal Mood Disorder
- Being tested
- Vitamin D, No Vitamin D
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Group will receive 5000 units of vitamin D daily
No Vitamin DDietary supplement
No vitamin D supplementation
| Study group | Role | What they receive |
|---|---|---|
| Non-vitamin D supplementation | Placebo comparator | Group not receiving vitamin D supplementation Receives: Dietary Supplement: No Vitamin D |
| Vitamin D supplementation | Experimental | Group receiving vitamin D supplementation Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Oct 2018
- Primary completion30 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Mood DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health South
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739671
- Sponsor's protocol ID
- MMMC#1580
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2018
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Vitamin D Supplementation in Emergency Medicine Residents and Seasonal Mood Symptoms
- ClinicalTrials.gov ID
- NCT03739671
- Acronym / sponsor ID
- MMMC#1580
- Conditions
- Seasonal Mood Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Corewell Health SouthUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 14 Nov 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-vitamin D supplementation | Placebo comparator | Dietary Supplement: No Vitamin DGroup not receiving vitamin D supplementation |
| Vitamin D supplementation | Experimental | Dietary Supplement: Vitamin DGroup receiving vitamin D supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PGY-2 and PGY-3 Emergency Medicine Residents at Lakeland Health
Key exclusion criteria (1 listed)
- Nonresidents and PGY-1 and PGY-4 Emergency Medicine residents at Lakeland Health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DGroup will receive 5000 units of vitamin D daily | Dietary supplement | Vitamin D supplementation |
| No Vitamin DNo vitamin D supplementation | Dietary supplement | Non-vitamin D supplementation |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and No Vitamin D in people with Seasonal Mood Disorder, run by Corewell Health South 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 1 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: finished, as of the sponsor's last update on 29 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of vitamin D on resident mood (time frame: 6 months). 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 29 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.