Vitamin D Supplementation for Bipolar Depression

U

University of Massachusetts, Worcester

Status

Completed

Conditions

Bipolar Disorder
Bipolar Depression

Treatments

Drug: Vitamin D3, Cholecalciferol
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01884844
NARSADYI13-15

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

33 participants in 2 patient groups, including a placebo group

Vitamin D3
Experimental group
Description:
Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks
Treatment:
Drug: Vitamin D3, Cholecalciferol
Placebo
Placebo Comparator group
Description:
methylcellulose po qday for 12weeks
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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