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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2021 |
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Main ID: |
NCT03792451 |
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Date of registration:
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31/12/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Nutrition Status of Adults Treated With Pegvaliase
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Scientific title:
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Nutrition Status of Adults With Phenylketonuria Treated With Pegvaliase |
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Date of first enrolment:
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January 17, 2019 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03792451 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Krista Viau, PhD, RD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of phenylketonuria
2. Aged 18-65 years
3. Currently treated with pegvaliase
4. Have either 1) received treatment with pegvaliase for one or more years or 2) followed
an unrestricted diet for 6 or more months while on pegvaliase
5. Currently following an unrestricted diet that meets or exceeds the RDA for protein
(0.8 g/kg/day)
Exclusion Criteria:
1. Unable to consent to study
2. Under age 18 years or over age 65
3. Routine food intake provides less than the RDA for protein (0.8 g/kg/d)
4. Consuming any PKU medical foods
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Phenylketonurias
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Intervention(s)
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Drug: Pegvaliase
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Primary Outcome(s)
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Mean concentrations of serum marker(s) of cardiovascular status
[Time Frame: through study completion, an average of 1 year]
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Mean concentrations of serum marker(s) of essential fatty acid status
[Time Frame: through study completion, an average of 1 year]
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Mean micronutrient intake (%DRI) as reported on a three-day food record
[Time Frame: through study completion, an average of 1 year]
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Mean concentrations of serum marker(s) of micronutrient status
[Time Frame: through study completion, an average of 1 year]
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Mean concentrations of serum marker(s) of protein status
[Time Frame: through study completion, an average of 1 year]
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Mean protein intake (g/day) as reported on a three-day food record
[Time Frame: through study completion, an average of 1 year]
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Secondary Outcome(s)
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Correlation between serum micronutrient concentrations and average micronutrient intake
[Time Frame: through study completion, an average of 1 year]
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Mean Healthy Eating Index-2015 scores calculated from the Diet History Questionnaire III
[Time Frame: through study completion, an average of 1 year]
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Secondary ID(s)
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P00029611
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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