Nutrition Status of Adults Treated With Pegvaliase

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03792451
Status
Completed

Conditions

  • Phenylketonurias

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Pegvaliase — DRUG
    Treated with pegvaliase for one or more years or followed an unrestricted diet for 6 or more months while being treated with pegvaliase.

Study Details

Conduct a cross-sectional analysis of the nutritional status of individuals with PKU treated with pegvaliase for one or more years or who have followed an unrestricted diet for 6 or more months while on pegvaliase treatment. We will evaluate laboratory markers of nutritional status, including markers of protein and micronutrient nutriture. In addition, a three-day food record and food frequency questionnaire will be obtained to assess protein intake and overall diet quality.

Key Dates

Start date
Jan 17, 2019
Status verified
Mar 2021
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
18 participants (actual)

Primary Outcome Measure

Mean concentrations of serum marker(s) of protein status [ Time Frame: through study completion, an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Boston Children's Hospital· Boston, MA

Related Studies