NCT02812134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

June 16, 2016

Last Update Submit

May 27, 2026

Conditions

Malnutrition

Keywords

phosphorus supplementationFGF23anorexicadolescentsundernutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

anorexic

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

anorexic patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

MalnutritionAnorexia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lydia LICHTENBERGER, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 24, 2016

Study Start

March 26, 2016

Primary Completion

June 16, 2017

Study Completion

June 16, 2017

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations

FR(1)