Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Hamilton 17 item scale (Hamilton-17)
研究概览
简要总结
The purpose of this study is to investigate whether patients with depression should be offered vitamin D supplements, or it has no significance in relation to treatment outcomes.
详细描述
Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D [25(OH)D], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D [1,25(OH)2D].
At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of [25(OH)D] in the blood and especially in the early spring months the levels of [25(OH)D] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3.
New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.
In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression.
The objective of this randomized clinical trial is to investigate whether patients with depression should be offered vitamin D3 supplements, or it has no significance in relation to treatment outcomes.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis unipolar depression
排除标准
- •clinical diagnosis sarcoidoses
- •tuberculosis
- •bipolar affective disorder
- •schizophrenia
- •hypercalcemia
- •hyperphosphatemia
- •electroconvulsive treatment for the last 6 months
- •primary diagnosis addiction
结局指标
主要结局
Hamilton 17 item scale (Hamilton-17)
时间窗: 24 weeks
Change from baseline in Hamilton-17 at week 24
次要结局
- WHO-Five Well-being Index (WHO-5)(24 weeks)