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Completed

NCT Number: NCT05357859

Vitamin D for Cognition in Bipolar Disorder

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei City hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

solubilized vitamin D3

Dietary Supplement

solubilized vitamin D3

medium chain triglyceride

Dietary Supplement

MCT with same amount

Primary outcomes

  1. change of cognition

    Time frame: Week 0, Week 10

    Change from Baseline Brief Assessment of Cognition in Affective Disorders (BAC-A) score at week 10

Secondary outcomes

  1. change of serum vitamin D levels

    Time frame: Week 0, Week 10

    change from baseline serum vitamin D levels to week 10, unit: ng/mL

  2. change of serum creatinine

    Time frame: Week 0, Week 10

    change from baseline serum creatinine to week 10, unit: mg/dL

  3. change of blood albumin

    Time frame: Week 0, Week 10

    change from baseline blood albumin to week 10, unit: g/dL

  4. change of blood parathyroid hormone

    Time frame: Week 0, Week 10

    change from baseline parathyroid hormone to week 10, unit: pg/mL

  5. change of serum calcium levels

    Time frame: Week 0, Week 10

    change from baseline serum calcium levels to week 10, unit: mg/dL

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Official study title

Effect of Vitamin D Supplement for Cognitive Function in Patients With Bipolar Disorder- Randomized Double-Blind Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 3, 2022
Registry last updated
Nov 22, 2023

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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