Clinical trial NCT02408679: Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
Official title: A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Vitamin D
Vitamin D Deficiency
Vitamin D Insufficiency
Healthy adults
Predictive questionnaire
Lead sponsor: Lesieur
Sponsor class: INDUSTRY
Collaborators: name: Naturalpha
First posted: 2015-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Questionnaire internal validity
timeFrame: Day 1
measure: Questionnaire external validity
timeFrame: Day 1
measure: Confounding factors (demographic data)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinical Nutrition Center Naturalpha (CNCN)
Study officials:
affiliation: Lesieur, France
name: Sylvie BRETON, R&D Innovation Manager
role: STUDY_DIRECTOR
affiliation: Clinical Nutrition Center Naturalpha, France
name: Xavier Deplanque, MD
role: PRINCIPAL_INVESTIGATOR
References: