Vitamin D for Cognition in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357859
• Other study ID #: vitamin D in bipolar
• Status: Completed
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 20, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Age of participants should range from 20 to 65 years old.

3. No history of vitamin D supplementation within three months before the study.

4. 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:

1. With known substance use disorder (except nicotine use disorder)

2. With any disorder with known neurological symptoms or complications (ex. brain injury, stroke or brain lesions)

3. Comorbid with schizophrenia spectrum disorders

4. With active physical condition (such as renal impairment, hepatic failure…) or pregnancy

5. Inability to complete the standard assessment or incapability of providing informed consent

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Dietary Supplement:
• solubilized vitamin D3
solubilized vitamin D3
• medium chain triglyceride
MCT with same amount

Locations

Country	Name	City	State
Taiwan	Taipei City hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of cognition	Change from Baseline Brief Assessment of Cognition in Affective Disorders (BAC-A) score at week 10	Week 0, Week 10
Secondary	change of serum vitamin D levels	change from baseline serum vitamin D levels to week 10, unit: ng/mL	Week 0, Week 10
Secondary	change of serum creatinine	change from baseline serum creatinine to week 10, unit: mg/dL	Week 0, Week 10
Secondary	change of blood albumin	change from baseline blood albumin to week 10, unit: g/dL	Week 0, Week 10
Secondary	change of blood parathyroid hormone	change from baseline parathyroid hormone to week 10, unit: pg/mL	Week 0, Week 10
Secondary	change of serum calcium levels	change from baseline serum calcium levels to week 10, unit: mg/dL	Week 0, Week 10