Taipei City hospital
Taipei, Taiwan
NCT Number: NCT05357859
Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D on cognitive performance in euthymic BD.
Looking for future studies?
Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Taipei, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
solubilized vitamin D3
MCT with same amount
Time frame: Week 0, Week 10
Change from Baseline Brief Assessment of Cognition in Affective Disorders (BAC-A) score at week 10
Time frame: Week 0, Week 10
change from baseline serum vitamin D levels to week 10, unit: ng/mL
Time frame: Week 0, Week 10
change from baseline serum creatinine to week 10, unit: mg/dL
Time frame: Week 0, Week 10
change from baseline blood albumin to week 10, unit: g/dL
Time frame: Week 0, Week 10
change from baseline parathyroid hormone to week 10, unit: pg/mL
Time frame: Week 0, Week 10
change from baseline serum calcium levels to week 10, unit: mg/dL
Taipei City Hospital
Other Gov
Effect of Vitamin D Supplement for Cognitive Function in Patients With Bipolar Disorder- Randomized Double-Blind Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06365021
Bipolar Disorder, Bipolar and Related Disorders
São Paulo, Brazil
View Trial DetailsNCT02481245
Bipolar Disorder, Bipolar and Related Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT03336918
Behavior, Behavioral Symptoms
Cleveland, Ohio, United States
View Trial DetailsNCT04696471
Bipolar Disorder, Bipolar and Related Disorders
Pittsburgh, Pennsylvania, United States
View Trial Details