Mental WellbeingNCT05724316
Effects of Vitamin D on the Behaviours, Mental, and Physical Health of Prisoners
A study testing Vitamin D supplement in people with Mental Wellbeing and Depression, Anxiety, run by Oxford Brookes University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Wellbeing, Depression, Anxiety, Bone Density, Low
- What is being tested?
- Vitamin D supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Long-term Residents (with minimum 1 year)
- Biological Male adults (+18)
- Have been residents for minimum of 3 months
- Understanding of the English language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
HMP Huntercombe
Henley on Thames, RG9 5SB
Matthew Poulter, MSc, 19184966@brookes.ac.uk
Matthew Poulter, MSc
About this study
Official title: Open Controlled Trial to Explore the Effectiveness of Vitamin D Supplements on the Behaviours, Mental, and Physical Health of United Kingdom Prison Residents
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.
Read the detailed description
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:
- To assess the prevalence of VD supplementation within prisons.
- To assess VD serum levels among male adult prisoner population.
- To assess whether VD supplementation in prisons can lead to improved markers of physical health, for example, grip strength, bone density.
- To assess whether VD supplementation in prisons can lead to an overall improvement of mental health wellbeing, including anxiety and depression severity, assessed using validated methods.
- To assess whether VD can lead to improved behaviour amongst prisoners, assessed using a self-reported aggression questionnaire, and governor adjudication reports.
Secondary Aims:
- To determine whether aim 2 is associated with individual differences in VD metabolism.
- To assess overall nutritional content and quality of prison dietary intake.
This research has five hypotheses:
- VD supplementation will improve Serum 25-hydroxyvitamin D (VD) levels.
- VD supplementation will reduce levels of anxiety and depression within the offender population (measured by GAD-7 and PHQ-9).
- VD will improve general mental well-being (measured by WEMWBS).
- VD supplementation will improve physical health outcomes within the offender population (measured by VD blood serum level, bone density, and grip strength)
- VD supplementation will reduce violence and aggressive behaviours (measured by Buss Perry AQ, and adjudication reports)
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:
- Demographic information: (age, sex, ethnicity/race, gender, level of education, custodial status and length)
- Health measures: (height, weight, body mass index (BMI), grip strength)
- Dietary intake: food diary (7-day food diary will be provided to participants)
- Self-Reported Questionnaires: Patient Health Questionnaire-9 (PHQ-9) (for depression), Generalised Anxiety Disorder Assessment (GAD-7) (for anxiety), Buss Perry Aggression Questionnaire (AQ) (for aggression), and WEMWBS (for general mental wellbeing)
- A survey question regarding time spent outside on average, and the date participant first took supplement (if applicable)
- Bone density
- Blood analysis (for VD serum) (researcher will be qualified for blood-taking procedures)
- Saliva analysis (for genetics)
From Prison
- Health history (including medications taking)
- Behaviour records (governor/officer reports, adjudication reports)
- Mental health history (i.e. any diagnoses/treatment for depression, anxiety, bipolar, schizophrenia, any reports of self-harm/suicide attempts)
- Substance use (any misuse history)
- Dietary issues (history of hunger strikes)
- Date of resident entry to prison and length of stay
After baseline, the following measures will be taken at the end of month 1 and month 2:
From Participant:
- Questionnaires: PHQ-9, GAD-7, AQ, and WEMWBS
- Log/Question regarding time spent outside
At the end of month 3, the following measures will be taken:
From Participant:
- Blood analysis: Serum 25-hydroxyvitamin D (25(OH)D)
- Bone density
- Grip strength
- Weight, height, and BMI
- 3- or 7-day food diary (will depend on what is discussed with identified prisons)
And the regular monthly measures:
- Questionnaires: PHQ-9, GAD-7, AQ, and WEMWBS
- Log/Question regarding time spent outside
- Being tested
- Vitamin D supplement
- Keywords
- Anxiety, Depression, Behaviour, Mental health, Mental wellbeing, Physical health, Bone health, Prisoners
- Medical subject headings
- Depression, Anxiety Disorders, Bone Diseases, Metabolic, Vitamin D Deficiency, Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementDietary supplement
Also called cholecalciferol (VD3 25μg) tablet
N/A (says not to repeat information here)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Group | Experimental | All participants in this group will receive cholecalciferol (VD3 25μg) tablets, one to be taken per day. Receives: Dietary Supplement: Vitamin D supplement |
| Control Group | No intervention | Will receive no vitamin D supplements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of month 3
Secondary outcomes (18)
Rule Violations
Measured by officer/governor reports and adjudication reports.
Measured: Baseline
Rule Violations
Measured by officer/governor reports and adjudication reports.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Month 3
Bone density
Bone density measured by Sonost 3000 bone densimeter.
Measured: Baseline
Bone density
Bone density measured by Sonost 3000 bone densimeter.
Measured: End of Month 3
Grip Strength
Grip strength as measured by a Takei Hand Grip Dynamometer.
Measured: Baseline
Grip Strength
Grip strength as measured by a Takei Hand Grip Dynamometer.
Measured: End of Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start18 Mar 2023
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One arm will receive vitamin D supplements, the other arm will not receive supplements.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- HM Prison and Probation Service, United Kingdom, Ministry of Justice, United Kingdom, University of Oxford, Practice Plus Group
- Responsible party
- Principal investigator, Jonathan Tammam, Oxford Brookes University
- Investigators
- Jonathan Tammam, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724316
- Sponsor's protocol ID
- 221634
- Status last verified
- Nov 2023
- First submitted
- 21 Dec 2022
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Controlled Trial to Explore the Effectiveness of Vitamin D Supplements on the Behaviours, Mental, and Physical Health of United Kingdom Prison Residents
- ClinicalTrials.gov ID
- NCT05724316
- Acronym / sponsor ID
- 221634
- Keywords
- Anxiety, Depression, Behaviour, Mental health, Mental wellbeing, Physical health, Bone health, Prisoners
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- HM Prison and Probation Service, United Kingdom, Ministry of Justice, United Kingdom, University of Oxford, Practice Plus Group
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To assess the prevalence of VD supplementation within prisons.
- To assess VD serum levels among male adult prisoner population.
- To assess whether VD supplementation in prisons can lead to improved markers of physical health, for example, grip strength, bone density.
- To assess whether VD supplementation in prisons can lead to an overall improvement of mental health wellbeing, including anxiety and depression severity, assessed using validated methods.
- To assess whether VD can lead to improved behaviour amongst prisoners, assessed using a self-reported aggression questionnaire, and governor adjudication reports.
Secondary Aims:
- To determine whether aim 2 is associated with individual differences in VD metabolism.
- To assess overall nutritional content and quality of prison dietary intake.
This research has five hypotheses:
- VD supplementation will improve Serum 25-hydroxyvitamin D (VD) levels.
- VD supplementation will reduce levels of anxiety and depression within the offender population (measured by GAD-7 and PHQ-9).
- VD will improve general mental well-being (measured by WEMWBS).
- VD supplementation will improve physical health outcomes within the offender population (measured by VD blood serum level, bone density, and grip strength)
- VD supplementation will reduce violence and aggressive behaviours (measured by Buss Perry AQ, and adjudication reports)
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:
- Demographic information: (age, sex, ethnicity/race, gender, level of education, custodial status and length)
- Health measures: (height, weight, body mass index (BMI), grip strength)
- Dietary intake: food diary (7-day food diary will be provided to participants)
- Self-Reported Questionnaires: Patient Health Questionnaire-9 (PHQ-9) (for depression), Generalised Anxiety Disorder Assessment (GAD-7) (for anxiety), Buss Perry Aggression Questionnaire (AQ) (for aggression), and WEMWBS (for general mental wellbeing)
- A survey question regarding time spent outside on average, and the date participant first took supplement (if applicable)
- Bone density
- Blood analysis (for VD serum) (researcher will be qualified for blood-taking procedures)
- Saliva analysis (for genetics)
From Prison
- Health history (including medications taking)
- Behaviour records (governor/officer reports, adjudication reports)
- Mental health history (i.e. any diagnoses/treatment for depression, anxiety, bipolar, schizophrenia, any reports of self-harm/suicide attempts)
- Substance use (any misuse history)
- Dietary issues (history of hunger strikes)
- Date of resident entry to prison and length of stay
After baseline, the following measures will be taken at the end of month 1 and month 2:
From Participant:
- Questionnaires: PHQ-9, GAD-7, AQ, and WEMWBS
- Log/Question regarding time spent outside
At the end of month 3, the following measures will be taken:
From Participant:
- Blood analysis: Serum 25-hydroxyvitamin D (25(OH)D)
- Bone density
- Grip strength
- Weight, height, and BMI
- 3- or 7-day food diary (will depend on what is discussed with identified prisons)
And the regular monthly measures:
- Questionnaires: PHQ-9, GAD-7, AQ, and WEMWBS
- Log/Question regarding time spent outside
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One arm will receive vitamin D supplements, the other arm will not receive supplements.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Group | Experimental | Dietary Supplement: Vitamin D supplementAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Long-term Residents (with minimum 1 year)
- Biological Male adults (+18)
- Have been residents for minimum of 3 months
- Understanding of the English language
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplementAlso: cholecalciferol (VD3 25μg) tabletN/A (says not to repeat information here) | Dietary supplement | Vitamin D Group |
Primary outcome
Mental wellbeing
Time frame: Baseline
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.
Mental wellbeing
Time frame: End of Month 1
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.
Mental wellbeing
Time frame: End of Month 2
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.
Mental wellbeing
Time frame: End of Month 3
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.
Vitamin D serum levels
Time frame: Baseline
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.
Vitamin D serum levels
Time frame: End of month 3
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.
18 secondary outcomes
Rule Violations
Time frame: Baseline
Rule Violations
Time frame: End of Month 3
Aggression
Time frame: Baseline
Aggression
Time frame: End of Month 1
Aggression
Time frame: End of Month 2
Aggression
Time frame: End of Month 3
Generalised anxiety
Time frame: Baseline
Generalised anxiety
Time frame: End of Month 1
Generalised anxiety
Time frame: End of Month 2
Generalised anxiety
Time frame: End of Month 3
Depression severity
Time frame: Baseline
Depression severity
Time frame: End of Month 1
Depression severity
Time frame: End of Month 2
Depression severity
Time frame: End of Month 3
Bone density
Time frame: Baseline
Bone density
Time frame: End of Month 3
Grip Strength
Time frame: Baseline
Grip Strength
Time frame: End of Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Tammam principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplement in people with Mental Wellbeing and Depression, Anxiety, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Tammam (+44 (0)1865 483245, jtammam@brookes.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental wellbeing (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.