Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All subjects

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.

Blood sampling

Intervention Type PROCEDURE

One blood sampling will be performed for a serum vitamin D dosage. The volume of blood collected will not exceed 4 ml.

Predictive questionnaire for vitamin D insufficiency

Intervention Type OTHER

The questionnaire includes 19 questions concerning the following topics : a) sun exposure, b) living situation, c) eating habits and Vitamin D dietary intakes. In addition, two questions will capture demographic data.

Interventions

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Blood sampling

One blood sampling will be performed for a serum vitamin D dosage. The volume of blood collected will not exceed 4 ml.

Intervention Type PROCEDURE

Predictive questionnaire for vitamin D insufficiency

The questionnaire includes 19 questions concerning the following topics : a) sun exposure, b) living situation, c) eating habits and Vitamin D dietary intakes. In addition, two questions will capture demographic data.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes