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

Malnutrition Clinical Trial

— IPSAASU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812134
• Other study ID #: PI2015_843_0006
• Status: Recruiting
• Start date: June 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Lydia LICHTENBERGER, PhD
• Phone: +33 3 22 08 76 60
• Email: lichtenberger.lydia[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Malnutrition

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FGF23	Change in the FGF23 level (U/ml) with regard to the exogenous phosphorus intake (doses of Phosphoneuros®, expressed in mg/kg/day)	at inclusion and then once a month for 6 months.