Effect of Vitamin D Supplement for Cognitive Function in Patients With Bipolar Disorder- Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- change of cognition
研究概览
简要总结
Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D on cognitive performance in euthymic BD.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo: MCT with same amount
control group will receive same volume amount of medium chain triglyceride (MCT).
干预措施: medium chain triglyceride (Dietary Supplement)
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.
干预措施: solubilized vitamin D3 (Dietary Supplement)
结局指标
主要结局
change of cognition
时间窗: Week 0, Week 10
Change from Baseline Brief Assessment of Cognition in Affective Disorders (BAC-A) score at week 10
次要结局
- change of serum vitamin D levels(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)
- change of serum creatinine(Week 0, Week 10)
研究者
Wen Yin Chen
Psychiatrist in Taipei City Hospital, songde branch
Taipei City Hospital