The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 主要终点
- Cognitive Function
研究概览
简要总结
The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Chronic schizophrenia
- •Serum 25(OH)D level below 30 ng/ml
- •Deficit in cognitive functions
排除标准
- •Hypercalcemia
- •Hepatic or renal failure
- •Metabolic syndrome
研究组 & 干预措施
Placebo
Oral placebo daily for 8 weeks
干预措施: Placebo (Drug)
Vitamin D
Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Cognitive Function
时间窗: At the end of week 8
cognitive function as measured with standard cognitive battery
次要结局
- BDNF serum level(At the end of week 8)
研究者
Tuti Kurnianingsih
Principal Investigator
Universitas Padjadjaran