Back to resultsVitamin D Supplementation for Bipolar Depression
Primary Purpose
Bipolar Disorder, Bipolar Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3, Cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
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
Sites / Locations
- University of Massachusettes
- University of Massachusetts School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D3
Placebo
Arm Description
Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks
methylcellulose po qday for 12weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01884844
First Posted
June 17, 2013
Last Updated
May 17, 2018
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT01884844
Brief Title
Vitamin D Supplementation for Bipolar Depression
Official Title
Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Bipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3
Arm Type
Experimental
Arm Description
Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
methylcellulose po qday for 12weeks
Intervention Type
Drug
Intervention Name(s)
Vitamin D3, Cholecalciferol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Montgomery-Åsberg Depression Rating Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Marsh, MD MSc
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusettes
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01604
Country
United States
Facility Name
University of Massachusetts School of Medicine
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D Supplementation for Bipolar Depression
We'll reach out to this number within 24 hrs