A double-blind, placebo controlled, randomized, comparative, mono-centre trial to assess the impact of a monthly administration of 50.000 IU of Vitamin D during 6 months on Vitamin D level in healthy young adult volunteers. - D-plus

Phase 1

• Conditions: Vitamine D deficiency; MedDRA version: 12.1Level: LLTClassification code 10047626Term: Vitamin D deficiency

• Registration Number: EUCTR2010-022454-17-BE
• Lead Sponsor: niversity of Liège- Dpt de Médecine Générale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Healthy young adults, male or female
-18-30 years
-Willing to give informed consent in writing
-French speaking
-Mental and legal capacity to give his consent
-Body mass index between (=) 18 and (=) 30 kg/m2
-Availability to study visits

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject using any over-the-counter medicinal products, herbal supplements within the last 30 days containing vitamin D within the last 2 months;
2.UV light solarium use
3.Subject treated for epilepsy (phenytoïn, phenobarbital, carbamazepin)
4.Subject treated with glucocorticoïds;
5.Subjects treated with digitalin, Calcium, thiazidics,
6.Past or current history of granulomatosis (Besnier-Boek-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer (of whatever origin), osteomalacia
7.Subject currently participating or within the last 3 months participated in another study of an Investigational Medicinal Product (IMP) that is a chemical entity or a medical device.
8.Subject with hypersensitivity or intolerance to any components of the IMP.
9.Subject has concurrent or past medical, surgical or psychiatric history that could, in the opinion of investigator, confound study interpretation or affect the subject’s ability to fully participate in the study.
10.Subject known to be positive for human immunodeficiency virus (HIV).
11.Known tuberculosis (TB) disease, high risk of acquiring TB infection
12.Subject known to have a history of acute chronic alcohol or drug abuse/dependence (including but not limited to cannabis) within the 6 months prior to Screening
13.Subject has a history of radiotherapy or chemotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: to evaluate the mean change versus baseline of a monthly administration of 50.000 I.U. 25 hydroxy-Vitamin D, during six consecutive months on plasma levels of Vit D in young healthy volunteers.;Secondary Objective: Secondary objectives: to evaluate the influence of Vit D supplementation on muscle strength, fatigue and infectious episodes frequently encountered during winter (rhinitis, pharyngitis, otitis, Influenza, and G.I. tract infections).;Primary end point(s): The primary efficacy endpoint is the mean change in 25-hydroxy Vitamin D levels between the baseline (D1) and the treatment period (D3). The mean change will be calculated as the ratio R=D3/D1 or its logarithm log (R). The mean changes in 25-hydroxy Vitamin D levels (primary endpoint) in the two study groups (investigational and comparator) will be compared by a two-sided Student t-test at the 5% significance level, based on the ITT population.