Vitamin D for Cognition in Bipolar Disorder

NCT05357859 | Completed

• 1 other identifier: vitamin D in bipolar
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder

Keywords

bipolar disorder; vitamin D; cognition

Outcome Measures

Primary Outcomes (1)

• change of cognition

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

  Week 0, Week 10

Secondary Outcomes (5)

• change of serum vitamin D levels

  Week 0, Week 10

• change of serum creatinine

  Week 0, Week 10

• change of blood albumin

  Week 0, Week 10

• change of blood parathyroid hormone

  Week 0, Week 10

• change of serum calcium levels

  Week 0, Week 10

Study Arms (2)

Intervention: solubilized vitamin D3 in MCT

EXPERIMENTAL

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.

Dietary Supplement: solubilized vitamin D3

Placebo: MCT with same amount

PLACEBO COMPARATOR

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

Dietary Supplement: medium chain triglyceride

Interventions

solubilized vitamin D3 DIETARY_SUPPLEMENT

solubilized vitamin D3

Intervention: solubilized vitamin D3 in MCT

medium chain triglyceride DIETARY_SUPPLEMENT

MCT with same amount

Placebo: MCT with same amount

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist in Taipei City Hospital, songde branch

Model Details: double blinded RCT

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 3, 2022
• Study Start: May 3, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 20, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)