Clinical trial NCT05357859: Vitamin D for Cognition in Bipolar Disorder
Official title: Effect of Vitamin D Supplement for Cognitive Function in Patients With Bipolar Disorder- Randomized Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: bipolar disorder
vitamin D
cognition
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-03
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blinded RCT
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: change of cognition
timeFrame: Week 0, Week 10
Secondary outcomes:
measure: change of serum vitamin D levels
timeFrame: Week 0, Week 10
measure: change of serum creatinine
timeFrame: Week 0, Week 10
measure: change of blood albumin
timeFrame: Week 0, Week 10
measure: change of blood parathyroid hormone
timeFrame: Week 0, Week 10
measure: change of serum calcium levels
timeFrame: Week 0, Week 10
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City hospital
Study officials:
References: