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

NCT ID: NCT02044133

Last Updated: 2025-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Male Prisoner

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Dosage Vitamine D

Intervention Type OTHER

Dosage of Vitamine D 6 month

Participant will have one dosage of vitamine D 6 month after entry to prison

Group Type OTHER

Dosage Vitamine D

Intervention Type OTHER

Interventions

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Dosage Vitamine D

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves BLEHER, PH

Role: PRINCIPAL_INVESTIGATOR

CHD Vendée La Roche sur Yon

Locations

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Centre hospitalier départemental Vendée

La Roche-sur-Yon, , France

Site Status

Countries

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France

Other Identifiers

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CHD026-12

Identifier Type: -

Identifier Source: org_study_id

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