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

NCT05724316 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-11-02

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D supplement

N/A (says not to repeat information here)

Sponsors & Collaborators

  • HM Prison and Probation Service, United Kingdom

    collaborator UNKNOWN
  • Ministry of Justice, United Kingdom

    collaborator UNKNOWN
  • University of Oxford

    collaborator OTHER
  • Practice Plus Group

    collaborator UNKNOWN
  • Oxford Brookes University

    lead OTHER

Principal Investigators

  • Jonathan Tammam · Oxford Brookes University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-18
Primary Completion
2024-01-31
Completion
2024-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05724316 on ClinicalTrials.gov