NCT02408679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

February 5, 2015

Last Update Submit

March 31, 2015

Conditions

Healthy Volunteers

Keywords

Vitamin DVitamin D DeficiencyVitamin D InsufficiencyHealthy adultsPredictive questionnaire

Outcome Measures

Primary Outcomes (3)

  • Questionnaire internal validity

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

    Day 1

  • Questionnaire external validity

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

    Day 1

  • Confounding factors (demographic data)

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

    Day 1

Study Arms (1)

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.

Procedure: Blood samplingOther: Predictive questionnaire for vitamin D insufficiency

Interventions

Blood samplingPROCEDURE

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

All subjects
Predictive questionnaire for vitamin D insufficiencyOTHER

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.

All subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Center Naturalpha (CNCN)

Lille, 59020, France

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sylvie BRETON, R&D Innovation Manager

    Lesieur, France

    STUDY DIRECTOR

  • Xavier Deplanque, MD

    Clinical Nutrition Center Naturalpha, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

April 3, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-03

Locations

FR(1)