Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| HM Prison and Probation Service, United Kingdom | UNKNOWN |
| Ministry of Justice, United Kingdom | UNKNOWN |
| University of Oxford | OTHER |
| Practice Plus Group |
Not provided
Not provided
Not provided
Not provided
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.
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:
Secondary Aims:
This research has five hypotheses:
Study Design:
A minimum of 100 participants (50 per group) will be sought for recruitment (+10% for attrition). The sample size is based on The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) which ideally recommends a minimum of 50 participants per group (100 total) to detect a difference of +/- 5 points. This sample size is calculated using a power of 0.8, at a significance level of 0.05.
Group 1 (experimental group) will be supplemented with VD (1x25ug VD3 cholecalciferol tablet per day), and group 2 will not be supplemented with VD (control group). Upon recruitment, participants will be identified as either taking VD, or not. Participants taking VD will be in Group 1, participants not taking VD will be in Group2 (control).
Baseline Measures:
From Participant:
From Prison
After baseline, the following measures will be taken at the end of month 1 and month 2:
From Participant:
At the end of month 3, the following measures will be taken:
From Participant:
And the regular monthly measures:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D Group | Experimental | All participants in this group will receive cholecalciferol (VD3 25μg) tablets, one to be taken per day. |
|
| Control Group | No Intervention | Will receive no vitamin D supplements. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D supplement | Dietary Supplement | N/A (says not to repeat information here) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rule Violations | Measured by officer/governor reports and adjudication reports. | Baseline |
| Rule Violations | Measured by officer/governor reports and adjudication reports. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Tammam | Contact | +44 (0)1865 483245 | jtammam@brookes.ac.uk | |
| Shelly Coe | Contact | +44 (0)1865 483839 | scoe@brookes.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Tammam | Oxford Brookes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HMP Huntercombe | Recruiting | Henley on Thames | RG9 5SB | United Kingdom |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D001851 | Bone Diseases, Metabolic |
| D014808 | Vitamin D Deficiency |
| D001519 | Behavior |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| UNKNOWN |
One arm will receive vitamin D supplements, the other arm will not receive supplements.
Not provided
Not provided
Not provided
Not provided
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 |
| End of Month 3 |
| Aggression | Aggression is measured by Buss-Perry Aggression Questionnaire (AQ). The Buss-Perry AQ consists of 34 statements, which participants answer recalling from the previous 2 weeks. Higher T-scores indicate a higher level of aggression. Participants rate each statement using a 5-point Likert scale. Scores are normalised to a scale of 0-1, with 1 representing the highest level of aggression. | Baseline |
| Aggression | Aggression is measured by Buss-Perry Aggression Questionnaire (AQ). The Buss-Perry AQ consists of 34 statements, which participants answer recalling from the previous 2 weeks. Higher T-scores indicate a higher level of aggression. Participants rate each statement using a 5-point Likert scale. Scores are normalised to a scale of 0-1, with 1 representing the highest level of aggression. | End of Month 1 |
| Aggression | Aggression is measured by Buss-Perry Aggression Questionnaire (AQ). The Buss-Perry AQ consists of 34 statements, which participants answer recalling from the previous 2 weeks. Higher T-scores indicate a higher level of aggression. Participants rate each statement using a 5-point Likert scale. Scores are normalised to a scale of 0-1, with 1 representing the highest level of aggression. | End of Month 2 |
| Aggression | Aggression is measured by Buss-Perry Aggression Questionnaire (AQ). The Buss-Perry AQ consists of 34 statements, which participants answer recalling from the previous 2 weeks. Higher T-scores indicate a higher level of aggression. Participants rate each statement using a 5-point Likert scale. Scores are normalised to a scale of 0-1, with 1 representing the highest level of aggression. | End of Month 3 |
| Generalised anxiety | Generalised anxiety disorder as measured by GAD-7. The minimum score is 0, the highest is 21. A higher score indicates higher levels of generalised anxiety. | Baseline |
| Generalised anxiety | Generalised anxiety disorder as measured by GAD-7. The minimum score is 0, the highest is 21. A higher score indicates higher levels of generalised anxiety. | End of Month 1 |
| Generalised anxiety | Generalised anxiety disorder as measured by GAD-7. The minimum score is 0, the highest is 21. A higher score indicates higher levels of generalised anxiety. | End of Month 2 |
| Generalised anxiety | Generalised anxiety disorder as measured by GAD-7. The minimum score is 0, the highest is 21. A higher score indicates higher levels of generalised anxiety. | End of Month 3 |
| Depression severity | Depression severity as measured by PHQ-9. Minimum score is 0, with the maximum of 27. A higher score indicates higher levels of depression. | Baseline |
| Depression severity | Depression severity as measured by PHQ-9. Minimum score is 0, with the maximum of 27. A higher score indicates higher levels of depression. | End of Month 1 |
| Depression severity | Depression severity as measured by PHQ-9. Minimum score is 0, with the maximum of 27. A higher score indicates higher levels of depression. | End of Month 2 |
| Depression severity | Depression severity as measured by PHQ-9. Minimum score is 0, with the maximum of 27. A higher score indicates higher levels of depression. | End of Month 3 |
| Bone density | Bone density measured by Sonost 3000 bone densimeter. | Baseline |
| Bone density | Bone density measured by Sonost 3000 bone densimeter. | End of Month 3 |
| Grip Strength | Grip strength as measured by a Takei Hand Grip Dynamometer. | Baseline |
| Grip Strength | Grip strength as measured by a Takei Hand Grip Dynamometer. | End of Month 3 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D010549 | Personal Satisfaction |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |