Vitamin D for Cognition in Bipolar Disorder

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    120
  • sponsor
    Taipei City Hospital
Updated on 12 July 2022
depression
depressed mood
mania

Summary

Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D on cognitive performance in euthymic BD.

Description

Bipolar disorder (BD) is a chronic mental disease related to recurrent episodes along with cognitive or functional decline. Comparing efficacy of pharmacological interventions targeting to treat cognitive deficit in BD is unexplored. The majority of the observational studies demonstrate a significant association between low serum vitamin D and compromised cognition in a wide range of neuropsychiatry diseases. Recent survey further revealed the high prevalence of hypovitamin D in BD. The effect of supplement and association between vitamin D and cognition in BD and the underlying mechanism is unclear.

The investigators will collect vitamin D levels and assess their association with cognition in a euthymic bipolar cohort (N=200) for screen. Then, the investigators estimate to recruit 120 of participants with cognitive deficits and combined vitamin D deficiency, to conduct a RCT. Participants will keep their usual treatment and will be randomized to receive either vitamin D supplement or a placebo for eight weeks. Cognitive test, adverse side effect, mood status and blood 25(OH)D levels and biomarkers will be measured before and after intervention.

Details
Condition Bipolar Disorder
Treatment solubilized vitamin D3, medium chain triglyceride
Clinical Study IdentifierNCT05357859
SponsorTaipei City Hospital
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who diagnosed with BD-I based on the Diagnostic and Statistical Manual (DSM-IV) criteria are consecutively referred by board-certified psychiatrists in Taipei City Hospital, Songde branch
Age of participants should range from 20 to 65 years old
No history of vitamin D supplementation within three months before the study
The BD patients in their euthymic state (both Hamilton Depression Rating Scale and Young Mania Rating Scale ≤ 8) and no change of their psychoactive medications in recent three months

Exclusion Criteria

With known substance use disorder (except nicotine use disorder)
With any disorder with known neurological symptoms or complications (ex. brain injury, stroke or brain lesions)
Comorbid with schizophrenia spectrum disorders
With active physical condition (such as renal impairment, hepatic failure…) or pregnancy
Inability to complete the standard assessment or incapability of providing informed consent
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