Hypovitaminosis D Prediction Score (SCOPYD)

December 20, 2018 updated by: Hospices Civils de Lyon

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

2592

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lyon Cedex 03, France, 69424
        • Hospices Civils de Lyon - Pôle IMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Men and women aged 18 to 70 years old

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D status
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.
Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.
Patients will fill a self-administered questionnaire the day of inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

The day of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D concentration level
Time Frame: The day of inclusion

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)
The day of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne-Marie SCHOTT-PETHELAZ, MD, PhD, Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2016

Primary Completion (Actual)

November 17, 2017

Study Completion (Actual)

November 17, 2017

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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