MalnutritionIPSAASUNCT02812134
Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.
An observational study of Malnutrition, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Malnutrition
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2016to 16 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: anorexic patients
Who may be able to join
- 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
Who cannot join
- Known pre-existing renal disorders
- Known constitutional disorders of phosphate-calcium metabolism
- Adult patients, legal guardianship, incarceration
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Malnutrition
- Keywords
- phosphorus supplementation, FGF23, anorexic, adolescents, undernutrition
- Medical subject headings
- Malnutrition, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| anorexic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FGF23
Change in the FGF23 level (U/ml) with regard to the exogenous phosphorus intake (doses of Phosphoneuros®, expressed in mg/kg/day)
Measured: at inclusion and then once a month for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start26 Mar 2016
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lydia LICHTENBERGER, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812134
- Sponsor's protocol ID
- PI2015_843_0006
- Acronym
- IPSAASU
- Status last verified
- May 2026
- First submitted
- 16 Jun 2016
- Last updated
- 28 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.
- ClinicalTrials.gov ID
- NCT02812134
- Acronym / sponsor ID
- IPSAASU / PI2015_843_0006
- Conditions
- Malnutrition
- Keywords
- phosphorus supplementation, FGF23, anorexic, adolescents, undernutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 26 Mar 2016 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anorexic | – | – |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- anorexic patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Known pre-existing renal disorders
- Known constitutional disorders of phosphate-calcium metabolism
- Adult patients, legal guardianship, incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia LICHTENBERGER, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FGF23 (time frame: at inclusion and then once a month for 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.