Vitamin D, Bones, Nutritional and Cardiovascular Status

NCT01832623 | Completed DMC

• 1 other identifier: 2011.688
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D

Keywords

Vitamin D; bone; cardiovascular status; nutritional status

Outcome Measures

Primary Outcomes (1)

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

  The HR-pQCT evaluates bones down to the level of the tiny individual elements that nature configures in a way that makes bones as strong as possible. HR-pQCT measures bone density and quantifies the three dimensional geometry, strength and microarchitecture of bone at the lower arm (radius) and lower leg (tibia).

  up to 3 months

Secondary Outcomes (3)

• Values and standard deviation of 25-OH vitamin D3 plasma concentration concentration in the population studied.

  Once. At inclusion (V1).

• To study the correlation between vitamin D plasma concentration and nutritional and pubertal status, cardiovascular status, inflammatory status .

  up to 3 months

• To evaluate the relation between bone parameters (HR-pQCT) and adipokines; and the relation between bone parameters and cardio-vascular data (blood pressure, IMT, EMT, lipid profile, endothelial function).

  up to 3 months

Study Arms (1)

Exploration of Vitamin D roles

EXPERIMENTAL

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

Other: Exploration of Vitamin D roles

Interventions

Exploration of Vitamin D roles 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

Exploration of Vitamin D roles

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Lyon, 69003, France

Location

Related Publications (1)

• 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.

  PMID: 29872964 RESULT

Study Officials

• Justine Bachetta, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 16, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 22, 2025

Record last verified: 2017-02

Locations

FR (1)