Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
Children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (SGA) often gain excessive weight during their treatment with these medications. This weight gain may result in the development of features of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way to prevent these complications. The investigators' hypothesis is that daily vitamin D supplementation in these patients will result in decreased levels of the markers of metabolic syndrome with associated reduction in waist circumference.
详细描述
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females between the ages 10 through 18 years,
- •Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)[62] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis,
- •Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA,
- •All subjects will be able to take the prescribed vitamin D by mouth,
- •All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL,
- •All subjects must reside in an in-patient psychiatric facility.
排除标准
- •Pregnant or lactating women,
- •Patients with mental retardation (intelligence quotient < 50),
- •Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,
- •Subjects with known history of parathyroid disorder,
- •Subjects with acquired or congenital disorders of vitamin D metabolism,
- •Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,
- •Subjects taking any weight loss medications, such as orlistat, and sibutramine,
- •Subjects on medications that might affect glucose levels, such as insulin or metformin.
研究组 & 干预措施
Vitamin D
干预措施: Ergocalciferols (Drug)
结局指标
主要结局
Change in Weight
时间窗: Baseline and 8 weeks
次要结局
- Changes in Serum Levels of C-reactive Protein.(Baseline and 8 weeks)
- HDL-cholesterol at Baseline and Post-treatment(Baseline and 8 weeks)
- Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment(Baseline and 8 weeks)
- LDL-cholesterol at Baseline and Post-treatment(Baseline and 8 weeks)
- Total Cholesterol at Baseline and Post-treatment(Baseline and 8 weeks)
- Triglycerides at Baseline and Post-treatment(Baseline and 8 weeks)
- Adiponectin at Baseline and Post-treatment(Baseline and 8 weeks)
- Leptin at Baseline and Post-treatment(Baseline and 8 weeks)
研究者
Benjamin U. Nwosu
Study Principal Investigator
University of Massachusetts, Worcester