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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02044133
First Posted: January 23, 2014
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
  Purpose

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 Intervention
Male Prisoner Other: Dosage Vitamine D

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Departemental Vendee:

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

Enrollment: 54
Study Start Date: January 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02044133     History of Changes
Other Study ID Numbers: CHD026-12
First Submitted: January 21, 2014
First Posted: January 23, 2014
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