Key Nutrients and Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in total cholesterol from pre-test (baseline) to post-test (after 4 months)
研究概览
简要总结
The purpose of the project is to investigate whether an intervention program with vitamin D supplementation is able to improve the biology of stress resilience as well as subjective well-being in individuals with antisocial behavior problems (forensic inpatients).
详细描述
This is a randomized control trial looking at the effects of vitamin D supplements on mental health in a group of forensic inpatients. More specific the effects of vitamin D will be investigated in relation to underlying biological mechanisms associated with resilience (e.g., serotonin, cortisol, heart rate variability and executive functioning), but also subjective well-being such as sleep quality, anxiety, depression, self-reported resilience and physical activity. About 100 participants will be randomized to an intervention group (vitamin D) or a control group (placebo). The intervention will last for 3-4 months. Pre-test will start in October/November 2017 and post-test in April/May 2018.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with intelligence quotient > 70 will be invited.
排除标准
- •Patients with intelligence quotient <70 will be excluded.
- •Patients already taking vitamin D.
- •Patients with psychotic disorders.
研究组 & 干预措施
Control group
Placebo capsule contains olive oil
干预措施: Placebo (Dietary Supplement)
Vitamin D group
Intervention is vitamin D supplement
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Change in total cholesterol from pre-test (baseline) to post-test (after 4 months)
时间窗: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured from blood sample
Change in triglycerides from pre-test (baseline) to post-test (after 4 months)
时间窗: Time for blood sample: about 10-15 minutes (at both pre and post-test)
Measured from blood sample
Change in heart rate variability from pre-test (baseline) to post-test (after 4 months)
时间窗: 5 minutes of baseline, during the cognitive testing (up to 60 minutes) and 5 minutes of recovery (at both pre and post test)
Change in vitamin D level in blood from pre-test (baseline) to post-test (after 4 months)
时间窗: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured from blood sample
Change in serotonin from pre-test (baseline) to post-test (after 4 months)
时间窗: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured form blood sample
Change in cortisol from pre-test (baseline) to post-test (after 4 months)
时间窗: 7 samples over 24 hours (at both pre and post-test)
Saliva
Change in performance on working memory tasks (N-back) from pre-test (baseline) to post-test (after 4 months)
时间窗: About 8-10 minutes (at both pre and post-test)
Computerized cognitive task
Change in performance on Tower of Hanoi Task from pre-test (baseline) to post-test (after 4 months)
时间窗: About 10-15 minutes (at bot pre and post-test)
Computerized cognitive task
Change in performance on Tower of London Task from pre-test (baseline) to post-test (after 4 months)
时间窗: About 10-15 minutes (at both pre and post test)
Computerized cognitive task
Change in lipoproteins from pre-test (baseline) to post-test (after 4 months)
时间窗: Time for blood sample: about 10-15 minutes (at both pre and post test)
Measured from blood sample
Change in performance on Iowa Gambling Task from pre-test (baseline) to post-test (after 4 months)
时间窗: About 15-20 minutes (at both pre and post test)
Computerized cognitive task
次要结局
- Change in sleep from pre-test (baseline) to post-test (after 4 months)(One week before intervention and one week after intervention (i.e., pre and post-test))
- Houston Non-Exercise Questionnaire(The physical activity log will be filled out weekly over the course of the study period (i.e., 24 -28 weeks) and estimated time per week is 10 minutes.)
- Change in self-reported depression (Beck Depression Inventory) from pre-test (baseline) to post-test (after 4 months)(About 5-10 minutes (at both pre and post-test))
- Change on Epworth Sleepiness Scale from pre-test (baseline) to post-test (after 4 months)(About 5-10 minutes (at both pre and post-test))
- Change in self-reported state and trait anxiety (STAI questionnaire) from pre-test (baseline) to post-test (after 4 months)(About 10 minutes (at both pre and post-test))
- Change in self-reported resilience (Connor-Davidson Resilience Scale 25) from pre-test (baseline) to post-test (after 4 months)(About 5 minutes (at both pre and post-test))
- Change in post-traumatic stress symptoms (Impact of event scale -Revised) from pre-test (baseline) to post-test (after 4 months)(About 5-10 minutes (at both pre and post-test))
研究者
Anita Lill Hansen
Professor
University of Bergen