Comparison between intake of a monthly dose of vitamin D (D-CURE®) against a daily dose of vitamin D (VISTA-D3®)

Phase 1

• Conditions: Vitamin D deficiency (10-20 ng/ml); MedDRA version: 19.0Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-003755-29-BE
• Lead Sponsor: ABORATOIRES SMB S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-28
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

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

Inclusion Criteria

Subjects must satisfy the following criteria before entering the study:

1)Male and female aged from 18 to 55 years inclusive;
2)Caucasian
3)Having a 25(OH)D3 =10 ng/ml and = 20 ng/ml at the screening visit.
4)Presenting a body mass index (BMI) between 18 and 25 kg/m² inclusive;
5)Able to comply with all study procedures;
6)Provide written informed consent to participate in the study, indicated by a personal signature and date on the subject consent form;
7)If the volunteer is female and of childbearing potential, she must be using an efficient means of birth control (IUD, OCS, spermicide + condom, vaginal ring, hormonal patch, implant), as determined by the investigator and provide a negative blood pregnancy test at the screening visit.

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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
Subjects who meet any of the following criteria will be excluded from participating in the study:

1)Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease;
2)Past or current granulomatosis (Besnier-Boek-Schaumann disease), sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia;
3)Abnormal digestive functions (obstructive jaundice, pancreatic insufficiency, cystic fibrosis, celiac disease, etc);
4)Subjects who have a serum creatinine > 150 µmol/L (corresponding to 17 mg/L) at screening;
5)Subjects who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
6)Subjects known to have, or at risk of contracting, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
7)Use of any vitamin D supplement alone or in association within 2 months before the screening visit and during the study;
8)UV light solarium use 2 months before the screening visit and during the study;
9)Travelling to regions with high UVB incidence in the last 2 months and during the study;
10)History of drug and/or alcohol abuse;
11)Use of any prohibited medication as detailed in the concomitant medication section;
12)Participation in any other clinical trial within 1 month of the screening visit;
13)Hypersensitivity to the active ingredient and/or excipients of D-CURE® or VISTA-D3®;
14)Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.

Study & Design

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