A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Psychopathology as measured by the PANSS
研究概览
简要总结
Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.
详细描述
Subjects with levels of Vitamin D between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on Vitamin D for three months or to start after a delay of three months. Those with levels below 7gn/ml will start immediately. All will be evaluated monthly with blood tests, PANSS, movement disorder ratings and information on health and progress from the clinical chart.
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
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-70,
- •Schizophrenia or Schizoaffective disorder
- •stabilized but not expecting to be discharged soon
- •capacity to give informed consent
排除标准
- •acutely psychotic
- •acutely medically ill
- •renal insufficiency
- •hypercalcemia
- •hyperparathyroidism
研究组 & 干预措施
Immediate Vitamin D3
Will start Vitamin D3 immediately
干预措施: Vitamin D3 (Dietary Supplement)
Three month delay
Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately)
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Psychopathology as measured by the PANSS
时间窗: 3 months
PANSS is being done every month
次要结局
- movement disorder(three months)
- General Health(three months)
研究者
Nigel Bark MD
Director of Scizhophrenia Research
Bronx Psychiatric Center