NCT06718842

Brief Summary

phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. PKU is usually associated with many metabolic complication including non-alcoholic fatty liver

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 2, 2024

Last Update Submit

December 2, 2024

Conditions

PhenylketonuriasNon Alcoholic Fatty Liver

Outcome Measures

Primary Outcomes (1)

  • alanine transamianse

    it is a serum liver enzyme

    it will be assessed after eight weeks

Secondary Outcomes (5)

  • aspartate tranaminase

    it will be assessed after eight weeks

  • Gamma-glutamyl Transferase

    it will be assessed after eight weeks

  • alkaline phosphatase

    it will be assessed after eight weeks

  • triglycerides

    it will be assessed after eight weeks

  • body mass index

    it will be assessed after eight weeks

Study Arms (2)

group I

EXPERIMENTAL

this Group I will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will perform walking program (online supervised free walking that will be applied daily for eight weeks)

Behavioral: walking free online supervised program

Group II

NO INTERVENTION

this Group II will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will act a waitlisted children

Interventions

walking free online supervised programBEHAVIORAL

this Group I will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will perform walking program (online supervised free walking that will be applied daily for eight weeks)

group I

Eligibility Criteria

Age9 Years - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • PKU children
  • obese children
  • fatty liver children (non-alcoholic fatty liver)

You may not qualify if:

  • cardiac children
  • diabetic children
  • neurogenic disorders
  • respiratory and renal problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

PhenylketonuriasNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    STUDY CHAIR

Central Study Contacts

Ali Isamil, Lecturer

CONTACT

0201005154209ali.mohamed@pt.cu.edu.eg

shimaaa bondok, PHD

CONTACT

02 101 565 5118dr.shymaa_bondok@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 5, 2024

Study Start

September 15, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations

EG(1)