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Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition. (IPSAASU)

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ClinicalTrials.gov Identifier: NCT02812134
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and inhibition of 1,25-OH vitamin D).

There are no published studies on the role of FGF23 in undernourished anorexic adolescents taking oral phosphorus supplements.


Condition or disease
Malnutrition

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.
Study Start Date : June 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Phosphorus

Group/Cohort
anorexic



Primary Outcome Measures :
  1. FGF23 [ Time Frame: at inclusion and then once a month for 6 months. ]
    Change in the FGF23 level (U/ml) with regard to the exogenous phosphorus intake (doses of Phosphoneuros®, expressed in mg/kg/day)



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
anorexic patients
Criteria

Inclusion Criteria:

  • Adolescents aged from 11 to 17
  • Follow-up or hospitalisation for anorexia
  • Overt undernutrition (clinical signs of undernutrition, body mass index and the Waterlow index)
  • Social security coverage

Exclusion Criteria:

  • Known pre-existing renal disorders
  • Known constitutional disorders of phosphate-calcium metabolism
  • Adult patients, legal guardianship, incarceration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812134


Contacts
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Contact: Lydia LICHTENBERGER, PhD +33 3 22 08 76 60 lichtenberger.lydia@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Lydia LICHTENBERGER, PhD    +33 3 22 08 76 60    lichtenberger.lydia@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Lydia LICHTENBERGER, PhD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02812134     History of Changes
Other Study ID Numbers: PI2015_843_0006
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Keywords provided by Centre Hospitalier Universitaire, Amiens:
phosphorus supplementation
FGF23
anorexic
adolescents
undernutrition

Additional relevant MeSH terms:
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Malnutrition
Anorexia
Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Appetite Depressants
Anti-Obesity Agents