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The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks |
|
| Placebo | Placebo Comparator | methylcellulose po qday for 12weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3, Cholecalciferol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Ã…sberg Depression Rating Scale | Montgomery-Ã…sberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. | baseline and at 12 week completion |
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Inclusion Criteria:
Exclusion Criteria:
Systemic diseases such as:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Marsh, MD MSc | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusettes | Worcester | Massachusetts | 01604 | United States | ||
| University of Massachusetts School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 | Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol |
| FG001 | Placebo | methylcellulose po qday for 12weeks Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 | Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol |
| BG001 | Placebo | methylcellulose po qday for 12weeks Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Montgomery-Ã…sberg Depression Rating Scale | Montgomery-Ã…sberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. | Comparison of bimonthly scale measurements (MADRS, between treatment groups over time were done fitting individual Generalized Linear Models (GLMs) using the initial baseline measurement as an adjustment. Significance was fixed at 0.05%. SPSS v. 23 used | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and at 12 week completion |
|
12weeks of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3 | Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| xerostomia | Gastrointestinal disorders | Systematic Assessment |
small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of the Bipolar Disorders Specialty Clinic | Department of Psychiatry, Universtity of Massachusetts | 508-334-5052 | wendy.marsh@umassmemorial.org |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Worcester |
| Massachusetts |
| 01605 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol |
| OG001 | Placebo | methylcellulose po qday for 12weeks Placebo |
|
|
|
| 0 |
| 16 |
| 10 |
| 16 |
| EG001 | Placebo | methylcellulose po qday for 12weeks Placebo | 0 | 17 | 9 | 17 |
| appetite decrease | Gastrointestinal disorders | Systematic Assessment |
|
| diarhea | Gastrointestinal disorders | Systematic Assessment |
|
| weakness | General disorders | Systematic Assessment |
|
| mild confustion | General disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| mild sedation | General disorders | Systematic Assessment |
|
| sexual dysfunction, any | Reproductive system and breast disorders | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |