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

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ClinicalTrials.gov Identifier: NCT02044133
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Male Prisoner Other: Dosage Vitamine D

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)
Study Start Date : January 2014
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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



Primary Outcome Measures :
  1. dosage of vitamin D [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044133


Locations
France
Centre hospitalier départemental Vendée
La Roche sur Yon, France, 85925
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
Principal Investigator: Yves BLEHER, PH CHD Vendée La Roche sur Yon

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02044133     History of Changes
Other Study ID Numbers: CHD026-12
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: July 2015

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents