Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Changes to depressive symptoms as assessed using the BDI-II score
研究概览
简要总结
This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with normal vitamin D levels will be monitored as controls, and they will not receive any intervention.
详细描述
Patients with chronic liver diseases regularly suffer from vitamin D deficiency and depression. A recent meta-analysis reported an inverse correlation between depression and vitamin D levels. Indeed, vitamin D receptor is present and genomic and nongenomic vitamin D receptor-mediated signalling has been described in brain.
This intervention study investigates whether vitamin D therapy ameliorates depressive symptoms in chronic liver disease patients.
The investigators hypothesise that depressive symptoms will improve upon vitamin D replacement therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women
- •over 18 years of age
- •chronic liver disease
排除标准
- •severe hepatic encephalopathy (CFF <35 Hz)
- •Interferon treatment
- •hypercalcaemia (>2.7 mmol/l) or hypercalciuria (>8.0 mmol/d) with or without hyperparathyroidism (>65.0 pg/ml)
- •history of calcium-containing kidney stones
- •allergy or hypersensitivity to any of the supplement ingredients: peanuts, soy, gelatin
- •sarcoidosis
- •stage IV or V Chronic Kidney Disease
- •Pregnancy
研究组 & 干预措施
Controls
These patients had normal vitamin D levels and did not receive any treatment with vitamin D.
Vitamin D supplement
20,000 IU cholecalciferol p.o for the first 7 days, and weekly thereafter for 6 months
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Changes to depressive symptoms as assessed using the BDI-II score
时间窗: 3 and 6 months
次要结局
- Changes to serum liver function tests, as assessed using standard clinical-chemical assays(3 and 6 months)
- Changes to bone density, as assessed using Dexa scans(at 12 months)
研究者
Dr. Caroline Stokes
Dr
Universität des Saarlandes