Open Controlled Trial to Explore the Effectiveness of Vitamin D Supplements on the Behaviours, Mental, and Physical Health of United Kingdom Prison Residents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Mental wellbeing
研究概览
简要总结
This study aims to understand how vitamin D (VD) affects human health. Typically, prisoners are low on vitamin D, as it is difficult to receive through diet, and is mostly obtained via exposure to the sun. The investigators predict that VD supplements could help improve overall mental well-being, as well as improve bone health. The investigators aim to recruit two groups of participants from a United Kingdom (UK) Prison, all of whom will participate via an informed consent process. The first group of prisoners will have chosen to take VD supplements, the second group will have chosen not to take VD supplements. At the start of the study, prisoners will have their bone density and blood VD levels tested. The investigators will also ask participants to complete a series of questionnaires to understand the state of mental well-being at the start of the study. Participants will be asked to complete a food diary to track dietary intake over the following week. Additionally, the investigators are interested in identifying what proportion of participants have a specific genetic makeup relating to their ability to metabolise VD, and participants will be asked to provide a saliva sample to test this. Every month following the start of the study, participants will be asked to complete the same questionnaires and food diary again. On the 3rd month, the investigators will again test the participants' bone density and blood levels of VD, to see whether supplementation has improved participant VD status. This study will run for a minimum of 3 months, up to a maximum of 6.
详细描述
Aim of this research:
This is a quantitative open-label controlled trial, aiming to assess the effect of VD supplementation, within offender populations (male adults 21+), on behaviours, physical and mental health outcomes.
Primary Aims:
- To assess the prevalence of VD supplementation within prisons.
- To assess VD serum levels among male adult prisoner population.
- To assess whether VD supplementation in prisons can lead to improved markers of physical health, for example, grip strength, bone density.
- To assess whether VD supplementation in prisons can lead to an overall improvement of mental health wellbeing, including anxiety and depression severity, assessed using validated methods.
- To assess whether VD can lead to improved behaviour amongst prisoners, assessed using a self-reported aggression questionnaire, and governor adjudication reports.
Secondary Aims:
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Long-term Residents (with minimum 1 year)
- •Biological Male adults (+18)
- •Have been residents for minimum of 3 months
- •Understanding of the English language
排除标准
- •Short term Residents (<1 year), residents at end of their sentence
- •Residents with conditions impacting nutrient absorption i.e. Crohn's disease/celiac disease
- •Residents already taking calcitriol (an active form of VD)
- •Any medical condition that would preclude a participant from taking VD supplements
- •Any medical condition which could interfere with VD metabolism
结局指标
主要结局
Mental wellbeing
时间窗: End of Month 3
Overall mental well-being as measured by The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). WEMWBS uses a five-point scale, with participants required to answer questions recalling from the previous 2 weeks. The minimum score is 14, the maximum score is 70. A high score indicates lower well-being.
Vitamin D serum levels
时间窗: End of month 3
Assessing the levels of serum vitamin D amongst participants, using blood serum. 25(OH)D of \< 20 ng/ml is considered vitamin D deficiency, and 25(OH)D of 21-29 ng/ml is considered insufficient.
次要结局
- Generalised anxiety(End of Month 3)
- Bone density(End of Month 3)
- Rule Violations(End of Month 3)
- Aggression(End of Month 3)
- Depression severity(End of Month 3)
- Grip Strength(End of Month 3)
研究者
Jonathan Tammam
Director Centre for Nutrition and Health
Oxford Brookes University