Vitamin D Supplementation for Bipolar Depression

NCT01884844 | Completed Results

• 1 other identifier: NARSADYI13-15
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Bipolar Disorder; Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and at 12 week completion

Study Arms (2)

Vitamin D3

EXPERIMENTAL

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

Drug: Vitamin D3, Cholecalciferol

Placebo

PLACEBO COMPARATOR

methylcellulose po qday for 12weeks

Drug: Placebo

Interventions

Vitamin D3, Cholecalciferol DRUG

Vitamin D3

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18years old
• Bipolar disorder (I,II or NOS),
• MADRS Score\>7 (mild),
• (OH)D level \<30ng/ml (insufficient).
• able to take the prescribed vitamin D by mouth

You may not qualify if:

• 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
• active suicidality,
• acute psychosis,
• active substance use\<6mo or
• pregnant or nursing females

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (2)

University of Massachusettes

Worcester, Massachusetts, 01604, United States

Location

University of Massachusetts School of Medicine

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Director of the Bipolar Disorders Specialty Clinic
• Organization: Department of Psychiatry, Universtity of Massachusetts

wendy.marsh@umassmemorial.org

508-334-5052

Study Officials

• Wendy Marsh, MD MSc

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 24, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)