Vitamin D for Cognition in Bipolar Disorder

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

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

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Dietary supplement: solubilized vitamin D3; Dietary supplement: medium chain triglyceride

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen Yin Chen; Phone Number: 0979307737; Email: wenyin19@gmail.com
• Study Contact Backup: Name: Zona Zhuang; Phone Number: 0979307737; Email: zona0519@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: solubilized vitamin D3; solubilized vitamin D3
Placebo Comparator: Placebo: MCT with same amount; control group will receive same volume amount of medium chain triglyceride (MCT).	Dietary supplement: medium chain triglyceride; MCT with same amount

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of cognition	Change from Baseline Brief Assessment of Cognition in Affective Disorders (BAC-A) score at week 10	Week 0, Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of serum vitamin D levels	change from baseline serum vitamin D levels to week 10, unit: ng/mL	Week 0, Week 10
change of serum creatinine	change from baseline serum creatinine to week 10, unit: mg/dL	Week 0, Week 10
change of blood albumin	change from baseline blood albumin to week 10, unit: g/dL	Week 0, Week 10
change of blood parathyroid hormone	change from baseline parathyroid hormone to week 10, unit: pg/mL	Week 0, Week 10
change of serum calcium levels	change from baseline serum calcium levels to week 10, unit: mg/dL	Week 0, Week 10

Collaborators and Investigators

• Sponsor: Taipei City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: cognition; bipolar disorder; vitamin D
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: vitamin D in bipolar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual patient data can be sharing with de-identification process after asking

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No