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Completed

NCT Number: NCT01884844

Vitamin D Supplementation for 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.

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Key information

Conditions

Bipolar Disorder Bipolar Depression Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusettes, Worcester, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3, Cholecalciferol

Drug

Placebo

Drug

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2013
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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