Vitamin D, Bones, Nutritional and Cardiovascular Status

NCT ID: NCT01832623

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-07-31

Brief Summary

Vitamin D is not seen anymore only as a phosphocalcic hormone, but also as having an effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular protection).

The link between vitamin D deficiency and osteomalacia lesions is well-known. In paediatrics, systematic vitamin D supplementation of infants and toddlers, associated with milk enrichment, has allowed an almost total disappearance of rickets. Vitamin D repletion was defined as the minimal concentration that enables the prevention of rickets in children and osteomalacia in adults, that is approximately 8 ng/mL (20 nmol/L). However, in 2010, most of the international experts agreed to set minimal threshold of 25 OH vitamin D serum concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D insufficiency in adults. In the paediatric population, the consensus is less obvious and we consider that a serum concentration of minimum 20 ng/mL is necessary.

A study on more than 200 children from Lyon, followed in the paediatric nephrology unit and having a renal function normal or sub-normal, demonstrated an important prevalence of vitamin D deficiency (75%) in adolescents and pre-adolescents.

Concurrently, the appearance of new bone imaging techniques (especially high-resolution peripheral quantitative computed tomography HR-pQCT) improved bone status evaluation in a non-invasive manner.

Given the new pathophysiological data on pleiotropic role of vitamin D (bone, cardiovascular system, adipose tissue) and given the proportion of French children possibly suffering from vitamin D deficiency, it seems urgent to actualize current recommendations regarding systematic supplementation in vitamin D. This transversal study on 200 healthy children and adolescents will allow to have an overview of vitamin D status in French healthy children and adolescents, studying with non-invasive, safe, reliable and innovative tools, the theoretical targets of vitamin D (bones, cardiovascular system and nutritional status); and then to lay the foundations of therapeutic trials aiming to evaluate the mode of vitamin D supplementation for healthy children and adolescents; while having a cohort for HR-pQCT measurements, that will allow us to have French reference range in a 10-17 year-old population, for this innovative, non-invasive and low radiation exposure technique.

Detailed Description

To study the correlation between bone assessment by high-resolution peripheral quantitative computed tomography (HR-pQCT) and vitamin D serum concentration.

Conditions

Vitamin D

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Exploration of Vitamin D roles

Various exams will be performed during two visits (the same day or within three months) in order to answer the objectives of the study.

Group Type: EXPERIMENTAL

Exploration of Vitamin D roles

Intervention Type: OTHER

• Visit 1: questioning, physical examination, blood sampling (including plasma collection for future genetic analyses), carotid ultrasound
• Visit 2 (same day as visit 1 or maxi 3 months later): HR-pQCT, dual energy x-ray absorptiometry (DXA), iontophoresis of acetylcholine and sodium nitroprusside

Interventions

Exploration of Vitamin D roles

• Visit 1: questioning, physical examination, blood sampling (including plasma collection for future genetic analyses), carotid ultrasound
• Visit 2 (same day as visit 1 or maxi 3 months later): HR-pQCT, dual energy x-ray absorptiometry (DXA), iontophoresis of acetylcholine and sodium nitroprusside

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 10 year-old <or= Age < 18 year-old
• Without mobility handicap (medical walker, crutch, wheelchair…)
• Written informed consent (signed by parents)

Exclusion Criteria

• History of treatment with growth hormone
• History of treatment with oral corticoids, taken over more than 3 consecutive months
• Current treatment with growth hormone, corticoids or anti-calcineurin
• Treatment with aspirin or nonsteroidal anti-inflammatory drug within the last three weeks
• Treatment with paracetamol within the last week
• Chronic pathology with an impact on growth:

• Parenteral nutrition
• Chronic inflammatory disease (rheumatologic or digestive notably)
• System diseases (lupus, granulomatosis, vascularitis)
• Renal failure
• Diabetes
• Serious intercurrent disease (infection, neoplasia)
• Ongoing pregnancy
• Patient unaffiliated with the French universal healthcare system.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justine Bachetta, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant - 69500 BRON - FRANCE

Locations

Hôpital Femme Mère Enfant

Lyon, , France

Countries

France

References

Preka E, Ranchin B, Doyon A, Vierge M, Ginhoux T, Kassai B, Bacchetta J. The interplay between bone and vessels in pediatric CKD: lessons from a single-center study. Pediatr Nephrol. 2018 Sep;33(9):1565-1575. doi: 10.1007/s00467-018-3978-3. Epub 2018 Jun 5.

Reference Type: RESULT

PMID: 29872964 (View on PubMed)

Other Identifiers

2011.688

Identifier Type: -

Identifier Source: org_study_id