Vitamin D Supplementation for Bipolar Depression

University of Massachusetts, Worcester33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bipolar Disorder Bipolar Depression

Interventions

Vitamin D3, CholecalciferolDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Massachusettes

Worcester, Massachusetts, United States

University of Massachusetts School of Medicine

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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