Male Prisoner
Conditions
Brief 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. the purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.
Interventions
OTHERDosage Vitamine D
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Incarcerated person * Imprisoned in La Roche sur Yon * Male * Age \> 18 year old * Not opposed to participation in the study
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosage of Vitamin D | 6 month | Vitamin D level in ng/mL |
Countries
France
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Dosage of Vitamine D 6 Month Participant will have one dosage of vitamine D 6 month after entry to prison
Dosage Vitamine D | 28 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | refusal of blood sampling | 0 | 1 |
| Overall Study | Release | 3 | 4 |
| Overall Study | Transfer | 1 | 0 |
Baseline characteristics
| Characteristic | Dosage of Vitamine D : Inclusion and 6 Month | Dosage of Vitamine D 6 Month | Total |
|---|---|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 8.5 | 35.3 years STANDARD_DEVIATION 11.9 | 32.5 years STANDARD_DEVIATION 10.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 28 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 28 |
| serious Total, serious adverse events | 0 / 26 | 0 / 28 |
Outcome results
Primary
Dosage of Vitamin D
Vitamin D level in ng/mL
Time frame: 6 month
Population: ITT analyse
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dosage of Vitamine D : Inclusion and 6 Month | Dosage of Vitamin D | 28.2 ng/mL | Standard Deviation 8.6 |
| Dosage of Vitamine D 6 Month | Dosage of Vitamin D | 14.6 ng/mL | Standard Deviation 9.8 |
p-value: <0.001Chi-squared