Commercial study conducted to determine the most adequate supplementation of vitamin D in patients showing vitamin D deficiency

Phase 1

• Conditions: Patients of 18 years of age or more with vitamin D deficiency; MedDRA version: 14.1Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-004917-14-BE
• Lead Sponsor: ABORATOIRES SMB S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-12
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

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

Inclusion Criteria

Patients must satisfy the following criteria before entering the study:
1)Male and female over 18 years old (18 years inclusive);
2)Having a 25 OH-vitamin D =5 ng/ml and =20 ng/ml at the screening visit.
3)Presenting a Body mass Index between 18 and 30 kg/m² inclusive;
4)Normal function of thyroid confirmed by normal TSH with or without treatment
5)Caucasian;
6)Able to comply with all study procedures;
7)Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form;
8)If the patient is female and of childbearing potential, she must be using an efficient means of birth control (IUD, OCS, spermicide + condom) , 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Patients 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 history of granulomatosis (Besnier-Boek-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia;
3)Patients who have a serum creatinine > 150 µmol/L (corresponding to 17 mg/L) at screening;
4)Patients who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
5)Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab).
6)Use of any vitamin D supplementation alone or in association within 4 weeks before the screening visit;
7)Use of any of the prohibited medication as detailed in the concomitant medication section;
8)UV light solarium use 2 weeks before the screening visit and during the study;
9)Travelling outside European countries during the study participation;
10)History of drug and/or alcohol abuse;
11)Patients with any sensitivity or allergy to any of the products used within this clinical trial;
12)Participation in any other clinical trial within 1 month of the screening visit;
13)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