Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults

Lesieur

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Predictive questionnaire for vitamin D insufficiency; Procedure: Blood sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT02408679

ID-RCB Number : 2014-A01633-44 (Other Identifier)

14-035

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the metrological properties of a questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood dosage.

Full description

Each subject will perform only one visit (visit V1). The study duration per subject will last about 2 hours. During this visit V1, the subjects will perform a medical exam in order to check their eligibility (general statement and check of inclusion / non-inclusion criteria). The eligible subjects will fill up a study questionnaire and will perform a blood sampling for a dosage of serum vitamin D.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female volunteers
• Subject able to communicate with the investigator and the study team, able to read and write and follow all study instructions.
• Written informed consent provided and signed prior screening, after receiving and understanding the subject information.
• Registered with the French Social Security, in agreement with the French law on biomedical experimentation.

Exclusion criteria

• Subject with diagnosed osteoporosis, osteopenia or osteomalacia.
• Subject with known disease that contributes in osteoporosis: Rheumatoid arthritis, Malabsorption syndrome, Inflammatory bowel disease, Hyperthyroidism, Hyperparathyroidism.
• Subject with known hepatic impairment.
• Subject with known liver impairment or with a history of renal transplantation.
• Subject with history of cancer.
• Subject with history of bariatric surgery.
• Subject taking or having taken osteoporosis inducing treatment, or treatment with an effect on calcium and phosphorus metabolism during the 3 months prior the visit: Corticosteroids, Enzyme inducing anticonvulsants, Heparin.
• Subject requiring vitamin D supplementation for a diagnosed pathology.
• Pregnant or breastfeeding Female.
• Subject with history of alcohol or drug abuse.
• Participation to any other clinical trial simultaneously and/or not having ended the exclusion period of another clinical trial.
• Subject of legal age unable of giving consent.
• Subject deprived of liberty by judicial or administrative decision.
• Subject of legal age under legal protection.
• Subject having received over 4500 Euros for clinical trial participation within the prior year including the indemnity for the present study.

Trial design

300 participants in 1 patient group

All subjects

Description:

300 eligible subjects will perform a blood sampling for a dosage of serum vitamin D and will fill up a study questionnaire during one visit.

Treatment:

Other: Predictive questionnaire for vitamin D insufficiency

Procedure: Blood sampling