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Vitamin D for Cognition in Bipolar Disorder

NCT ID: NCT05357859

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2023-11-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blinded RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
A pharmacist will prepare the dosing of solubilized vitamin D3 and also identical appearance of placebo according to a randomized block schedule. Patients and researchers were blinded to treatment assignment.

Study Groups

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Intervention: solubilized vitamin D3 in MCT

The intervention dose and duration aims to correct their vitamin D deficiency to sufficient status (total serum 25(OH)D \>/=30 ng/mL or 75 nmol/L). According to an oral cholecalciferol (D3) loading dose guideline for vitamin D-deficient adults (van Groningen et al. 2010), cumulative dose of more than 200,000 IU solubilized vitamin D3 would be applied in current RCT, with make sure the sufficient supplement. Intervention group will receive 144,000 IU in week0 (W0) and then every 2 weeks of 72,000 IU for total 8 weeks (totally 5 times: 144,000 IU wk0/ 72,000 IU wk2/ 72,000 IU wk4/ 72,000 IU wk6/ 72,000 IU wk8), theoretically to achieve sufficient levels of vitamin D.

Group Type EXPERIMENTAL

solubilized vitamin D3

Intervention Type DIETARY_SUPPLEMENT

solubilized vitamin D3

Placebo: MCT with same amount

control group will receive same volume amount of medium chain triglyceride (MCT).

Group Type PLACEBO_COMPARATOR

medium chain triglyceride

Intervention Type DIETARY_SUPPLEMENT

MCT with same amount

Interventions

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solubilized vitamin D3

solubilized vitamin D3

Intervention Type DIETARY_SUPPLEMENT

medium chain triglyceride

MCT with same amount

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wen Yin Chen

Psychiatrist in Taipei City Hospital, songde branch

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei City hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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vitamin D in bipolar

Identifier Type: -

Identifier Source: org_study_id