Vitamin D Supplementation for Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884844
• Other study ID #: NARSADYI13-15
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: May 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Vitamin D3, Cholecalciferol

• Placebo

Locations

Country	Name	City	State
United States	University of Massachusettes	Worcester	Massachusetts
United States	University of Massachusetts School of Medicine	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and at 12 week completion