## Protocol Section
### Identification Module
**NCT ID:** NCT02408679

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 14-035
#### Organization
**Class:** INDUSTRY
**Full Name:** Lesieur
#### Secondary ID Infos
**Domain:** ANSM
**ID:** ID-RCB Number : 2014-A01633-44
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2015-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-04-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-02

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2015-04-03
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-05
**Study First Submit QC Date:** 2015-03-31
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Naturalpha

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Lesieur

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy Volunteers

**Keywords:**

- Vitamin D

- Vitamin D Deficiency

- Vitamin D Insufficiency

- Healthy adults

- Predictive questionnaire

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Procedure: Blood sampling

- Other: Predictive questionnaire for vitamin D insufficiency

**Label:** All subjects

### Interventions

#### Intervention 1

**Arm Group Labels:**

- All subjects

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

**Name:** Blood sampling

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- All subjects

**Description:** 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.

**Name:** Predictive questionnaire for vitamin D insufficiency

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules

**Measure:** Questionnaire internal validity

**Time Frame:** Day 1

**Description:** Prediction of the vitamin D status (threshold value, sensitivity, specificity for vitamin D insufficiency; threshold value, sensitivity, specificity for vitamin D deficiency)

**Measure:** Questionnaire external validity

**Time Frame:** Day 1

**Description:** Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).

**Measure:** Confounding factors (demographic data)

**Time Frame:** Day 1

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Healthy Volunteers

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lille

**Country:** France

**Facility:** Clinical Nutrition Center Naturalpha (CNCN)

**Zip:** 59020

#### Overall Officials

**Official 1:**

**Affiliation:** Lesieur, France

**Name:** Sylvie BRETON, R&D Innovation Manager

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Clinical Nutrition Center Naturalpha, France

**Name:** Xavier Deplanque, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17551

- Name: Vitamin D Deficiency

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000050071

- Term: Bone Density Conservation Agents

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: HIGH

- As Found: Ultrasound

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014807

- Term: Vitamin D

### Misc Info Module

- Version Holder: 2024-05-24
