NCT01185574已完成不适用
Vitamin D for Improving Metabolic Control and Depressive Symptoms in Women With Diabetes; The Sunshine Study
Loyola University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Metabolic control
研究概览
简要总结
This study will examine whether weekly vitamin D supplementation in women with significant depressive symptoms and diabetes will exhibit improved mood and metabolic control. If supplementation with Vitamin D is beneficial, it will be a simple and cost-effective method for treatment. Women will be targeted since they have greater depression and worse metabolic control than men with diabetes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 and older
- •medically stable type 2 diabetes with HBA1c <9%.
- •significantly elevated depressive symptoms as measured by a score greater than or equal to 14 using the Center for Epidemiologic Studies Depression Tool (CES-D.
排除标准
- •vitamin D levels of 32 ng/dl or greater
- •malabsorption problems (e.g., crohn's disease, celiac sprue)
- •hypercalcemia-level greater than 10.5 mg/dl
- •Severe complications of diabetes (amputation, blindness, or renal problems) 5) Women with low thyroid function
- •active suicidal ideation, a history of bipolar depression, psychotic disorders, and current alcohol or substance disorders. Active treatment for depression (e.g., antidepressant therapy) will not be exclusion criteria 7) Any serious chronic illness that may impact on their health-related quality of life and treatment effect 8) Women who are pregnant 9) Women who have had bariatric surgery.
结局指标
主要结局
Metabolic control
时间窗: 6 months
次要结局
- depressive symptoms(6 months)
研究者
Sue Penckofer
Professor
Loyola University
研究点 (2)
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