Effects of Vitamin D on the Behaviours, Mental, and Physical Health of Prisoners
Open Controlled Trial to Explore the Effectiveness of Vitamin D Supplements on the Behaviours, Mental, and Physical Health of United Kingdom Prison Residents
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedStudy Start
First participant enrolled
March 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedNovember 2, 2023
November 1, 2023
10 months
December 21, 2022
November 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Mental wellbeing
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.
Baseline
Mental wellbeing
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.
End of Month 1
Mental wellbeing
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.
End of Month 2
Mental wellbeing
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.
End of Month 3
Vitamin D serum levels
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.
Baseline
Vitamin D serum levels
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.
End of month 3
Secondary Outcomes (18)
Rule Violations
Baseline
Rule Violations
End of Month 3
Aggression
Baseline
Aggression
End of Month 1
Aggression
End of Month 2
- +13 more secondary outcomes
Study Arms (2)
Vitamin D Group
EXPERIMENTALAll participants in this group will receive cholecalciferol (VD3 25μg) tablets, one to be taken per day.
Control Group
NO INTERVENTIONWill receive no vitamin D supplements.
Interventions
N/A (says not to repeat information here)
Eligibility Criteria
You may qualify if:
- Long-term Residents (with minimum 1 year)
- Biological Male adults (+18)
- Have been residents for minimum of 3 months
- Understanding of the English language
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxford Brookes Universitylead
- HM Prison and Probation Service, United Kingdomcollaborator
- Ministry of Justice, United Kingdomcollaborator
- University of Oxfordcollaborator
- Practice Plus Groupcollaborator
Study Sites (1)
HMP Huntercombe
Henley on Thames, RG9 5SB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Tammam
Oxford Brookes University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Centre for Nutrition and Health
Study Record Dates
First Submitted
December 21, 2022
First Posted
February 13, 2023
Study Start
March 18, 2023
Primary Completion
January 1, 2024
Study Completion
March 1, 2024
Last Updated
November 2, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
Due to the nature of the participants included, we are undecided on whether raw data will be shared at this time. This will be reviewed later on with the collaborators.