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Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02408679
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Naturalpha
Information provided by (Responsible Party):
Lesieur

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.

Condition or disease Intervention/treatment
Healthy Volunteers Procedure: Blood sampling Other: Predictive questionnaire for vitamin D insufficiency

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
Study Start Date : January 2015
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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

Other: 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.




Primary Outcome Measures :
  1. Questionnaire internal validity [ Time Frame: Day 1 ]
    Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules

  2. Questionnaire external validity [ Time Frame: Day 1 ]
    Prediction of the vitamin D status (threshold value, sensitivity, specificity for vitamin D insufficiency; threshold value, sensitivity, specificity for vitamin D deficiency)

  3. Confounding factors (demographic data) [ Time Frame: Day 1 ]
    Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Volunteers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408679


Locations
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France
Clinical Nutrition Center Naturalpha (CNCN)
Lille, France, 59020
Sponsors and Collaborators
Lesieur
Naturalpha
Investigators
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Study Director: Sylvie BRETON, R&D Innovation Manager Lesieur, France
Principal Investigator: Xavier Deplanque, MD Clinical Nutrition Center Naturalpha, France

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Responsible Party: Lesieur
ClinicalTrials.gov Identifier: NCT02408679    
Other Study ID Numbers: 14-035
ID-RCB Number : 2014-A01633-44 ( Other Identifier: ANSM )
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015
Keywords provided by Lesieur:
Vitamin D
Vitamin D Deficiency
Vitamin D Insufficiency
Healthy adults
Predictive questionnaire
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents