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Not Yet Recruiting NCT05724316

Effects of Vitamin D on the Behaviours, Mental, and Physical Health of Prisoners

Conditions: Mental Wellbeing, Depression, Anxiety, Bone Density, Low, Vitamin D Deficiency, Behavior

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 110
Sponsor: Oxford Brookes University

Summary

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 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 them to complete a series of questionnaires to understand their 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, we will again test their bone density and blood levels of VD, to see whether supplementation has improved their VD status. This study will run for a minimum of 3 months, up to a maximum of 6.

Eligibility Criteria

Inclusion Criteria:Long-term Residents (with minimum 1 year)Biological Male adults (+18)Have been residents for minimum of 3 monthsUnderstanding of the English languageExclusion Criteria:Short term Residents (<1 year), residents at end of their sentenceResidents with conditions impacting nutrient absorption i.e. Crohn's disease/celiac diseaseResidents already taking calcitriol (an active form of VD)Any medical condition that would preclude a participant from taking VD supplementsAny medical condition which could interfere with VD metabolism

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05724316). StuddyBuddy aggregates publicly available trial information.