Male PrisonerNCT02044133
Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)
A study testing Dosage Vitamine D in people with Male Prisoner, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry. 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
- Male Prisoner
- What is being tested?
- Dosage Vitamine D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Incarcerated person
- Imprisoned in La Roche sur Yon
- Male
- Age > 18 year old
- Not opposed to participation in the study
Who cannot join
- Intellectual deficit not to understand the study
- Taking osteoporosis treatment or any other affecting the metabolism of vitamin D
- Renal failure, liver failure
- Hypercalcemia
- Thyroid dysfunction, parathyroid diseases
- Duration of imprisonment less than the expected duration of the study.
- Incarcerated person who had received supplementation of vitamin D in the 6 months prior
Trial locations and contacts
1 site in 1 country.
About this study
The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry.
the purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.
- Conditions
- Male Prisoner
- Being tested
- Dosage Vitamine D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage Vitamine DOther
| Study group | Role | What they receive |
|---|---|---|
| Dosage of vitamine D : inclusion and 6 month | Other | Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry Receives: Other: Dosage Vitamine D |
| Dosage of Vitamine D 6 month | Other | Participant will have one dosage of vitamine D 6 month after entry to prison Receives: Other: Dosage Vitamine D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of Vitamin D
Vitamin D level in ng/mL
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Male PrisonerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves BLEHER, PH, Principal investigator, CHD Vendée La Roche sur Yon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044133
- Sponsor's protocol ID
- CHD026-12
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2014
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)
- ClinicalTrials.gov ID
- NCT02044133
- Acronym / sponsor ID
- CHD026-12
- Conditions
- Male Prisoner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry.
the purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosage of vitamine D : inclusion and 6 month | Other | Other: Dosage Vitamine DParticipant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry |
| Dosage of Vitamine D 6 month | Other | Other: Dosage Vitamine DParticipant will have one dosage of vitamine D 6 month after entry to prison |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Incarcerated person
- Imprisoned in La Roche sur Yon
- Male
- Age > 18 year old
- Not opposed to participation in the study
Key exclusion criteria (7 listed)
- Intellectual deficit not to understand the study
- Taking osteoporosis treatment or any other affecting the metabolism of vitamin D
- Renal failure, liver failure
- Hypercalcemia
- Thyroid dysfunction, parathyroid diseases
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 |
|---|---|---|
| Dosage Vitamine D | Other | Dosage of Vitamine D 6 month, Dosage of vitamine D : inclusion and 6 month |
Primary outcome
Dosage of Vitamin D
Time frame: 6 month
Vitamin D level in ng/mL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yves BLEHER, PH principal investigator
CHD Vendée La Roche sur Yon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosage Vitamine D in people with Male Prisoner, run by Centre Hospitalier Departemental Vendee at 1 site in France.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 12 Sep 2025. 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 France. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of Vitamin D (time frame: 6 month). 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 12 Sep 2025.