Vitamin D Supplementation for Bipolar Depression

NCT ID: NCT01884844

Last Updated: 2018-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Bipolar Disorder Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D3

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

Group Type EXPERIMENTAL

Vitamin D3, Cholecalciferol

Intervention Type DRUG

Placebo

methylcellulose po qday for 12weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vitamin D3, Cholecalciferol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Wendy Marsh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy Marsh, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Massachusettes

Worcester, Massachusetts, United States

Site Status

University of Massachusetts School of Medicine

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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NARSADYI13-15

Identifier Type: -

Identifier Source: org_study_id

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