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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Centre Hospitalier Departemental Vendee
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier:
NCT02044133
First received: January 21, 2014
Last updated: August 18, 2014
Last verified: August 2014
  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: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044133

Contacts
Contact: Lucie AUZANNEAU, ARC 02 51 44 63 80 lucie.auzanneau@chd-vendee.fr

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

No publications provided

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02044133     History of Changes
Other Study ID Numbers: CHD026-12
Study First Received: January 21, 2014
Last Updated: August 18, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

Additional relevant MeSH terms:
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014