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Early Dietary Treated Patients With Phenylketonuria Can Achieve Normal Growth and Mental Development.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302194
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Monica Ibrahim, Assiut University

Brief Summary:
The study aim is to follow up body growth(body weight by kg, length by cm, head circumference, abdominal circumference, and body mass index ) and mental development of infants on phenylalanine restricted diet in comparison with normal matchable infants.

Condition or disease Intervention/treatment
Phenylketonurias Dietary Supplement: phenylalanine restricted diet

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Early Dietary Treated Patients With Phenylketonuria Can Achieve Normal Growth and Mental Development.
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : October 2021


Group/Cohort Intervention/treatment
Patients with Phenylketonuria Dietary Supplement: phenylalanine restricted diet
Infants with hyperphenylalaninemia on special formula and diet

normal healthy children Dietary Supplement: phenylalanine restricted diet
Infants with hyperphenylalaninemia on special formula and diet




Primary Outcome Measures :
  1. Normal growth in early dietary treated patients with Phenylketonuria to assessed by body mass index in kg/m^2 [ Time Frame: one year ]
    Normal growth in early dietary treated patients with Phenylketonuria to assessed by body mass index in kg/m^2

  2. Normal growth in Early dietary treated patients with Phenylketonuria to assessed by head circumference in centimeters [ Time Frame: one year ]
    Normal growth in Early dietary treated patients with Phenylketonuria to assessed by head circumference in centimeters

  3. Normal growth in Early dietary treated patients with Phenylketonuria to assessed by abdominal circumference in centimeters [ Time Frame: one year ]
    Normal growth in Early dietary treated patients with Phenylketonuria to assessed by abdominal circumference in centimeters

  4. Mental development in early dietary treated patients with Phenylketonuria to assessed by using Emerging Pattern Of Behavior of infants [ Time Frame: one year ]
    Mental development in early dietary treated patients with Phenylketonuria to assessed by using Emerging Pattern Of Behavior of infants

  5. Comparison between early dietary treated patients with Phenylketonuria with normal matchable infants regarding normal growth and mental development [ Time Frame: one year ]
    Comparison between early dietary treated patients with Phenylketonuria with normal matchable infants regarding normal growth and mental development



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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cases:Infants with hyperphenylalaninemia on special formula and diet Controls: normal healthy children match with cases in the same social class, age and sex
Criteria

Inclusion Criteria:

  1. Infants with hyperphenylalaninemia on special formula and diet
  2. Infants of both sexes
  3. Age since birth till three years
  4. Type of feeding : diet restriction of phenylalanine
  5. Controls: normal healthy children match with cases in the same social class, age and sex

Exclusion Criteria:

  1. Age greater than three years
  2. Patients diagnosed with PKU and not regular in feeding for special diet and formula.
  3. PKU patients not diagnosed since birth

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): NCT04302194


Contacts
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Contact: Monica Dobs 01220777433 monicaibrahim9111@gmail.com
Contact: Shaimaa Khalaf 01001400503

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Farouk Hassanein Assiut University
Publications:

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Responsible Party: Monica Ibrahim, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04302194    
Other Study ID Numbers: Phenylketonuria
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phenylketonurias
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases