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

January 26, 2016 updated by: Centre Hospitalier Departemental Vendee

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Départemental VENDEE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
Other: Dosage Vitamine D
OTHER: Dosage of Vitamine D 6 month
Participant will have one dosage of vitamine D 6 month after entry to prison
Other: Dosage Vitamine D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dosage of vitamin D
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: Yves BLEHER, PH, Chd Vendee La Roche Sur Yon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (ESTIMATE)

January 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD026-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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