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Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?


N/A
10 Years
17 Years
Open (Enrolling)
Both
Vitamin D

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Trial Information

Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?


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


Inclusion Criteria:



- 10 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

- 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

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.

Outcome Description:

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).

Outcome Time Frame:

up to 3 months

Safety Issue:

No

Principal Investigator

Justine Bachetta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2011.688

NCT ID:

NCT01832623

Start Date:

February 2013

Completion Date:

May 2015

Related Keywords:

  • Vitamin D
  • Vitamin D
  • bone
  • cardiovascular status
  • nutritional status

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