Vitamin D Supplementation for Bipolar Depression

Not Applicable

Completed

• Conditions: Bipolar Disorder; Bipolar Depression
• Interventions: Drug: Vitamin D3, Cholecalciferol; Drug: Placebo

• Registration Number: NCT01884844
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2018-02-01
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Results First Posted: 2018-06-19
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3, Cholecalciferol	Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks
Placebo	Placebo	methylcellulose po qday for 12weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University of Massachusettes; 🇺🇸 Worcester, Massachusetts, United States

University of Massachusetts School of Medicine; 🇺🇸 Worcester, Massachusetts, United States