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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Dosage of Vitamine D 6 month | Other | Participant will have one dosage of vitamine D 6 month after entry to prison |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dosage Vitamine D | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dosage of Vitamin D | Vitamin D level in ng/mL | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves BLEHER, PH | CHD Vendée La Roche sur Yon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier départemental Vendée | La Roche-sur-Yon | 85925 | France |
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Participants were recruted based on physicien referral between september 2013 and january 2016. The first participant was enrolled on january 29, 2014 and the last participant was enrolled in july 15, 2015. 54 patients met inclusion criteria and were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dosage of Vitamine D : Inclusion and 6 Month | Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry Dosage Vitamine D |
| FG001 | Dosage of Vitamine D 6 Month | Participant will have one dosage of vitamine D 6 month after entry to prison Dosage Vitamine D |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dosage of Vitamine D : Inclusion and 6 Month | Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry Dosage Vitamine D |
| BG001 | Dosage of Vitamine D 6 Month |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dosage of Vitamin D | Vitamin D level in ng/mL | ITT analyse | Posted | Mean | Standard Deviation | ng/mL | 6 month |
|
The planned follow-up period for patients is six months until the M6 visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dosage of Vitamine D : Inclusion and 6 Month | Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry Dosage Vitamine D |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Yves BLEHER | Centre hospitalier départemental Vendée | 0251446572 | yves.bleher@ght85.fr |
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| Release |
|
| Transfer |
|
| refusal of blood sampling |
|
Participant will have one dosage of vitamine D 6 month after entry to prison
Dosage Vitamine D
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Dosage of Vitamine D 6 Month | Participant will have one dosage of vitamine D 6 month after entry to prison Dosage Vitamine D | 0 | 28 | 0 | 28 |
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