Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)

Not Applicable

Completed

• Conditions: Male Prisoner
• Interventions: Other: Dosage Vitamine D

• Registration Number: NCT02044133
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Status Verified: 2015-07
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dosage of Vitamine D 6 month	Dosage Vitamine D	Participant will have one dosage of vitamine D 6 month after entry to prison
Dosage of vitamine D : inclusion and 6 month	Dosage Vitamine D	Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry

Primary Outcome Measures

Name	Time	Method
dosage of vitamin D	6 month

Trial Locations

Locations (1)

Centre hospitalier départemental Vendée; 🇫🇷 La Roche sur Yon, France