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Trial record 7 of 80 for:    "phenylketonuria"

Simplified Diet Approach in Phenylketonuria

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ClinicalTrials.gov Identifier: NCT02555579
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jill Skrabal, University of Nebraska

Brief Summary:

This is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (PKU).

Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to participate in this study.

Subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about their attitudes towards their current Phe counting system.


Condition or disease Intervention/treatment Phase
Phenylketonuria Behavioral: Dietary Protein Counting and Free Fruits and Vegetables Not Applicable

Detailed Description:

This is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (PKU).

Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to participate in this study.

Subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about their attitudes towards their current Phe counting system.

Upon enrollment, a 3-day food record and Phe levels over the past 12 months will be collected. Demographic information will be asked, as well as questions regarding their current Phe counting system. Patients will be educated on the new counting system, stressing 3 key principles: 1) free use of fruits and vegetables, low in protein, 2) protein counting as a simpler version of Phe counting, including reinforcement of label reading, and 3) daily use of PKU formula for enhanced nutrient and protein intake. Patients will be given written educational tools to reinforce this new method.

At the end of the 12 months, subjects will be asked to provide a 3-day food record, and questions will be asked about their attitudes toward the use of the new simplified system.

Phenylalanine levels from the 12-month study period will be used to compare with historical data.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Dietary Protein and Free Fruits and Vegetables to Improve Metabolic Control Among Teens and Adults With Phenylketonuria: A Mixed Methods Approach
Actual Study Start Date : October 26, 2015
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017



Intervention Details:
  • Behavioral: Dietary Protein Counting and Free Fruits and Vegetables
    Subjects will be educated on new simplified diet approach and phenylalanine levels will be monitored for 1 year, and will be compared to 12 months prior to study enrollment


Primary Outcome Measures :
  1. Metabolic Control in Teens and Adults with PKU [ Time Frame: 12 months ]
    phenylalanine levels


Secondary Outcome Measures :
  1. attitudes towards simplified diet approach [ Time Frame: 12 months ]
    qualitative data collection



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Positive diagnosis of PKU
  2. Males and females >13 year of age
  3. Currently on phenylalanine-restricted diet

Exclusion Criteria:

  1. Any woman planning, or becoming pregnant during study duration
  2. Any patient who starts Kuvan during the study, as Kuvan lowers phenylalanine levels in some patients.
  3. Any patient currently enrolled in other research studies (Prism 301/302 Protocol; Institutional Review Board Protocol # 376-13-FB)

Responsible Party: Jill Skrabal, Metabolic Dietitian, University of Nebraska
ClinicalTrials.gov Identifier: NCT02555579     History of Changes
Other Study ID Numbers: 451-15-EP
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2015

Additional relevant MeSH terms:
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