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Hypovitaminosis D Prediction Score

NCT ID: NCT02822651

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2017-11-17

Brief Summary

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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.

Detailed Description

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Conditions

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Vitamin D Status

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

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

self-administered questionnaire

Intervention Type OTHER

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

Interventions

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Blood sampling

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

Intervention Type BIOLOGICAL

self-administered questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Marie SCHOTT-PETHELAZ, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospices Civils de Lyon - Pôle IMER

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL15_0078

Identifier Type: -

Identifier Source: org_study_id