Vitamin D Supplementation for Bipolar Depression

University of Massachusetts, Worcester

Status: Completed

Conditions: Bipolar Disorder; Bipolar Depression

Treatments: Drug: Vitamin D3, Cholecalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01884844

NARSADYI13-15

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Vitamin D3

Experimental group

Description:

Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks

Treatment:

Drug: Vitamin D3, Cholecalciferol

Placebo

Placebo Comparator group

Description:

methylcellulose po qday for 12weeks

Treatment:

Drug: Placebo