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

INTERVENTION: Trade Name: D‐cure®. Pharmaceutical Form: Oral solution INN or Proposed INN: COLECALCIFEROL CAS Number: 67‐97‐0 Current Sponsor code: D‐plus Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER‐DISPERSIBLE FORM) Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 25000‐ Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use CONDITION: Vitamine D deficiency ; MedDRA version: 12.1 Level: LLT Classification code 10047626 Term: Vitamin D deficiency PRIMARY OUTCOME: 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. 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. 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). 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