Healthy VolunteersNCT02408679
Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
An observational study of Healthy Volunteers, run by Lesieur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Blood sampling and Predictive questionnaire for vitamin D insufficiency
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
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.
Read the 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
- Healthy Volunteers
- Being tested
- Blood sampling, Predictive questionnaire for vitamin D insufficiency
- Keywords
- Vitamin D, Vitamin D Deficiency, Vitamin D Insufficiency, Healthy adults, Predictive questionnaire
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood sampling; Other: Predictive questionnaire for vitamin D insufficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire internal validity
Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules
Measured: 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)
Measured: Day 1
Confounding factors (demographic data)
Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesieur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Naturalpha
- Responsible party
- Sponsor
- Investigators
- Sylvie BRETON, R&D Innovation Manager, Study director, Lesieur, FranceXavier Deplanque, MD, Principal investigator, Clinical Nutrition Center Naturalpha, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408679
- Sponsor's protocol ID
- 14-035
- Other IDs
- ID-RCB Number : 2014-A01633-44
- Status last verified
- Mar 2015
- First submitted
- 5 Feb 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
- ClinicalTrials.gov ID
- NCT02408679
- Acronym / sponsor ID
- 14-035
- Conditions
- Healthy Volunteers
- Keywords
- Vitamin D, Vitamin D Deficiency, Vitamin D Insufficiency, Healthy adults, Predictive questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- LesieurIndustry (pharma, biotech, devices)
- Collaborators
- Naturalpha
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Procedure: Blood sampling, Other: Predictive questionnaire for vitamin D insufficiency300 eligible subjects will perform a blood sampling for a dosage of serum vitamin D and will fill up a study questionnaire during one visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingOne blood sampling will be performed for a serum vitamin D dosage. The volume of blood collected will not exceed 4 ml. | Procedure or surgery | All subjects |
| Predictive questionnaire for vitamin D insufficiencyThe 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. | Other | All subjects |
Primary outcome
Questionnaire internal validity
Time frame: Day 1
Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules
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)
Confounding factors (demographic data)
Time frame: Day 1
Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie BRETON, R&D Innovation Manager study director
Lesieur, France
Xavier Deplanque, MD principal investigator
Clinical Nutrition Center Naturalpha, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Lesieur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire internal validity (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.