Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01832623
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2013-04-05
Brief Title:
Vitamin D Bones Nutritional and Cardiovascular Status
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Are Bone Nutritional and Cardiovascular Status of French Children and Adolescents Correlated With Their Vitamin D Status
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITADOS
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 ngmL 20 nmolL 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 ngmL 50 nmolL to define a vitamin D deficiency and a limit of 30 ngmL 75 nmolL 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 ngmL 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
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 ngmL 20 nmolL 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 ngmL 50 nmolL to define a vitamin D deficiency and a limit of 30 ngmL 75 nmolL 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 ngmL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None