Vitamin D StatusSCOPYDNCT02822651
Hypovitaminosis D Prediction Score
A study testing Blood sampling and self-administered questionnaire in people with Vitamin D Status, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency (<10ng/ml). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status
- What is being tested?
- Blood sampling and self-administered questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,592 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2016to 17 Nov 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 70 years old
Who cannot join
- Participation in a study related to vitamin D
- Taking at least 80 000 IU vitamin D in the last 3 months as a single dose
- Pregnancy or breast-feeding
- Renal failure : severe renal impairment, dialysis, having kidney transplant
- Known hepatic impairment
- Gastrointestinal disorders: Celiac disease, Crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma
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- Known primary hypo/hyperparathyroidism
- Bone cancer/metastases current or in the last 2 years
- Treatment with antiepileptics
- Long-term treatment with glucocorticoids (> 3 months)
- Treatment with antiretroviral
- Legal incapacity or limited legal capacity
- Non-recipient of French Social Security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D
Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency (<10ng/ml).
Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.
We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.
- Conditions
- Vitamin D Status
- Being tested
- Blood sampling, self-administered questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.
self-administered questionnaireOther
Patients will fill a self-administered questionnaire the day of inclusion
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D status | Experimental | The 2500 subjects included in this unique arm will complete a self-administered questionnaire and will have a blood sampling to measure vitamin D blood concentration. Receives: Biological: Blood sampling; Other: self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
25 (OH) vitamin D blood concentration
Vitamin D determination will be carried out for each center in a single laboratory by chemiluminescence technique.
Vitamin D determination is the gold standard for the development and validation phases of the score. It will define the variables of the self-administered questionnaire to be included in the final score (development phase) and be the gold standard in the evaluation of the performance score (validation phase). The blood sample will be collected after the completion of the questionnaire, on the same day.
Measured: The day of inclusion
Secondary outcomes (1)
Vitamin D concentration level
The ability of the score to classify adults in one of these three categories:
- Category 1 : Vitamin D sufficiency (≥30 ng/ml)
- Category 2 : Hypovitaminosis D between 30 and 10 ng/ml
- Vitamin D insufficiency (<30 ng/ml)
- Vitamin D deficiency (<20 ng/ml)
- Category 3 : Severe deficiency (<10 ng/ml)
Measured: The day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start19 Sep 2016
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D StatusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie SCHOTT-PETHELAZ, MD, PhD, Principal investigator, Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822651
- Sponsor's protocol ID
- 69HCL15_0078
- Acronym
- SCOPYD
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Viprey M, Merle B, Riche B, Freyssenge J, Rippert P, Chakir MA, Thomas T, Malochet-Guinamand S, Cortet B, Breuil V, Chapurlat R, Lafage Proust MH, Carlier MC, Fassier JB, Haesebaert J, Caillet P, Rabilloud M, Schott AM. Development and Validation of a Predictive Model of Hypovitaminosis D in General Adult Population: SCOPYD Study. Nutrients. 2021 Jul 23;13(8):2526. doi: 10.3390/nu13082526.
PubMed 34444687
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D
- ClinicalTrials.gov ID
- NCT02822651
- Acronym / sponsor ID
- SCOPYD / 69HCL15_0078
- Conditions
- Vitamin D Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,592 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 4 Jul 2016 (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.
Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency (<10ng/ml).
Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.
We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D status | Experimental | Biological: Blood sampling, Other: self-administered questionnaireThe 2500 subjects included in this unique arm will complete a self-administered questionnaire and will have a blood sampling to measure vitamin D blood concentration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 18 to 70 years old
Key exclusion criteria (13 listed)
- Participation in a study related to vitamin D
- Taking at least 80 000 IU vitamin D in the last 3 months as a single dose
- Pregnancy or breast-feeding
- Renal failure : severe renal impairment, dialysis, having kidney transplant
- Known hepatic impairment
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 samplingPatients will have a blood sampling at inclusion to measure vitamin D blood concentration. | Biological | Vitamin D status |
| self-administered questionnairePatients will fill a self-administered questionnaire the day of inclusion | Other | Vitamin D status |
Primary outcome
25 (OH) vitamin D blood concentration
Time frame: The day of inclusion
Vitamin D determination will be carried out for each center in a single laboratory by chemiluminescence technique. Vitamin D determination is the gold standard for the development and validation phases of the score. It will define the variables of the self-administered questionnaire to be included in the final score (development phase) and be the gold standard in the evaluation of the performance score (validation phase). The blood sample will be collected after the completion of the questionnaire, on the same day.
1 secondary outcome
Vitamin D concentration level
Time frame: The day of inclusion
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 19 Dec 2025.
- Results publication: PubMed 34444687Viprey M, Merle B, Riche B, Freyssenge J, Rippert P, Chakir MA, Thomas T, Malochet-Guinamand S, Cortet B, Breuil V, Chapurlat R, Lafage Proust MH, Carlier MC, Fassier JB, Haesebaert J, Caillet P, Rabilloud M, Schott AM. Development and Validation of a Predictive Model of Hypovitaminosis D in General Adult Population: SCOPYD Study. Nutrients. 2021 Jul 23;13(8):2526. doi: 10.3390/nu13082526.
- Individual participant dataSharing planned: No
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Vitamin D 25-Hydroxylase Deficiency, Undernutrition
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Vitamin D Status and Its Influencing Factors in Zhejiang Province: A Multicenter Cross-Sectional Study
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Vitamin D Status and Clinical Outcomes in Locally Advanced Cervical Cancer
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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.
Anne-Marie SCHOTT-PETHELAZ, MD, PhD principal investigator
Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and self-administered questionnaire in people with Vitamin D Status, run by Hospices Civils de Lyon 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 1 inclusion and 13 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 19 Dec 2025. 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?
25 (OH) vitamin D blood concentration (time frame: The day of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822651, which also lists 1 linked publication.
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 19 Dec 2025; AzTrials last refreshed its copy on 29 Oct 2026.