NCT02822651

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,592

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

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

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

June 30, 2016

Last Update Submit

December 13, 2025

Conditions

Vitamin D Status

Outcome Measures

Primary Outcomes (1)

  • 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.

    The day of inclusion

Secondary Outcomes (1)

  • Vitamin D concentration level

    The day of inclusion

Study Arms (1)

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.

Biological: Blood samplingOther: self-administered questionnaire

Interventions

Blood samplingBIOLOGICAL

Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.

Vitamin D status
self-administered questionnaireOTHER

Patients will fill a self-administered questionnaire the day of inclusion

Vitamin D status

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Men and women aged 18 to 70 years old

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Pôle IMER

Lyon, 69424, France

Location

Related Publications (1)

  • 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.

    PMID: 34444687RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Anne-Marie SCHOTT-PETHELAZ, MD, PhD

    Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

September 19, 2016

Primary Completion

November 17, 2017

Study Completion

November 17, 2017

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)