Open Controlled Trial to Explore the Effectiveness of Vitamin D Supplements on the Behaviours, Mental, and Physical Health of United Kingdom Prison Residents

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• Long-term Residents (with minimum 1 year)

• Biological Male adults (+18)

• Have been residents for minimum of 3 months

• Understanding of the English language

Locations
Other Locations
United Kingdom
HMP Huntercombe
RECRUITING
Henley On Thames
Contact Information
Primary
Jonathan Tammam
jtammam@brookes.ac.uk
+44 (0)1865 483245
Backup
Shelly Coe
scoe@brookes.ac.uk
+44 (0)1865 483839
Time Frame
Start Date: 2023-03-18
Estimated Completion Date: 2024-03
Participants
Target number of participants: 110
Treatments
Experimental: Vitamin D Group
All participants in this group will receive cholecalciferol (VD3 25μg) tablets, one to be taken per day.
No_intervention: Control Group
Will receive no vitamin D supplements.
Related Therapeutic Areas
Sponsors
Collaborators: Practice Plus Group, Ministry of Justice, United Kingdom, HM Prison and Probation Service, United Kingdom, University of Oxford
Leads: Oxford Brookes University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials