Bipolar Depression, Bipolar Disorder
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults \>18years old * Bipolar disorder (I,II or NOS), * MADRS Score\>7 (mild), * 25(OH)D level \<30ng/ml (insufficient). * able to take the prescribed vitamin D by mouth
Exclusion criteria
Systemic diseases such as: * liver and kidney diseases, * known parathyroid disorder, * disorders of vitamin D metabolism, * taking vitamin D replacement therapy, * fat digestion disorder, * diabetes mellitus, * gi surgery * If the serum calcium in the range 2.50-2.55 mmol L, inclusion required a serum PTH below 5.0 pmol L-acute psychiatric urgency: * active suicidality, * acute psychosis, * active substance use\<6mo or * pregnant or nursing females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery-Åsberg Depression Rating Scale | baseline and at 12 week completion | Montgomery-Åsberg 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D3 Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks
Vitamin D3, Cholecalciferol | 16 |
| Placebo methylcellulose po qday for 12weeks
Placebo | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Placebo | Total | Vitamin D3 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 33 Participants | 16 Participants |
| Age, Continuous | 43.3 years STANDARD_DEVIATION 12.9 | 44.2 years STANDARD_DEVIATION 13.1 | 45.2 years STANDARD_DEVIATION 13.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 30 Participants | 15 Participants |
| Region of Enrollment United States | 17 participants | 33 participants | 16 participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 17 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 16 | 9 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Change in Montgomery-Åsberg Depression Rating Scale
Montgomery-Åsberg 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.
Time frame: baseline and at 12 week completion
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D3 | Change in Montgomery-Åsberg Depression Rating Scale | 9.4 units on a scale |
| Placebo | Change in Montgomery-Åsberg Depression Rating Scale | 6.4 units on a scale |
p-value: 0.89Fisher Exact