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Completed

NCT Number: NCT02822651

Hypovitaminosis D Prediction Score

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.

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Key information

Conditions

Vitamin D Status

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Pôle IMER

Lyon, 69424, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

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

Self-Administered Questionnaire

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D

Acronym: SCOPYD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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