Vitamin D Supplementation for Bipolar Depression

May 17, 2018 updated by: Wendy Marsh, University of Massachusetts, Worcester

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01604
        • University of Massachusettes
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3
Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks
Drug: Vitamin D3, Cholecalciferol
Placebo Comparator: Placebo
methylcellulose po qday for 12weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery-Åsberg Depression Rating Scale
Time Frame: 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.
baseline and at 12 week completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Wendy Marsh, MD MSc, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NARSADYI13-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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