Trial Outcomes & Findings for Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D) (NCT NCT02044133)

NCT ID: NCT02044133

Last Updated: 2025-09-12

Results Overview

Vitamin D level in ng/mL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 6 month
• Results posted on: 2025-09-12

Participant Flow

Participants were recruted based on physicien referral between september 2013 and january 2016. The first participant was enrolled on january 29, 2014 and the last participant was enrolled in july 15, 2015. 54 patients met inclusion criteria and were randomized.

Participant milestones

Measure	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 Dosage Vitamine D	Dosage of Vitamine D 6 Month Participant will have one dosage of vitamine D 6 month after entry to prison Dosage Vitamine D
Overall Study STARTED	26	28
Overall Study COMPLETED	20	22
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	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 Dosage Vitamine D	Dosage of Vitamine D 6 Month Participant will have one dosage of vitamine D 6 month after entry to prison Dosage Vitamine D
Overall Study Lost to Follow-up	1	1
Overall Study Death	1	0
Overall Study Release	3	4
Overall Study Transfer	1	0
Overall Study refusal of blood sampling	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Dosage of Vitamine D : Inclusion and 6 Month n=26 Participants Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry Dosage Vitamine D	Dosage of Vitamine D 6 Month n=28 Participants Participant will have one dosage of vitamine D 6 month after entry to prison Dosage Vitamine D	Total n=54 Participants Total of all reporting groups
Age, Continuous	29.6 years STANDARD_DEVIATION 8.5 • n=26 Participants	35.3 years STANDARD_DEVIATION 11.9 • n=28 Participants	32.5 years STANDARD_DEVIATION 10.7 • n=54 Participants
Sex: Female, Male Female	0 Participants n=26 Participants	0 Participants n=28 Participants	0 Participants n=54 Participants
Sex: Female, Male Male	26 Participants n=26 Participants	28 Participants n=28 Participants	54 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 month

Population: ITT analyse

Vitamin D level in ng/mL

Outcome measures

Measure	Dosage of Vitamine D : Inclusion and 6 Month n=26 Participants Participant will have one dosage of vitamine D to entrance of prison and one dosage of vitamine D 6 month after entry Dosage Vitamine D	Dosage of Vitamine D 6 Month n=28 Participants Participant will have one dosage of vitamine D 6 month after entry to prison Dosage Vitamine D
Dosage of Vitamin D	28.2 ng/mL Standard Deviation 8.6	14.6 ng/mL Standard Deviation 9.8

Adverse Events

Dosage of Vitamine D : Inclusion and 6 Month

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dosage of Vitamine D 6 Month

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Yves BLEHER

Centre hospitalier départemental Vendée

Phone: 0251446572

Email: yves.bleher@ght85.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place