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Educational, Social Support, and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria

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Disease Information

Descriptive Information
Brief Title † Educational, Social Support, and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria
Official Title † Educational, Social Support, and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria (PKU) or Maple Syrup Urine Disease (MSUD).
Brief Summary The purpose of this project is to study the effectiveness of teaching teens and young women with Phenylketonuria (PKU) or Maple Syrup Urine Disease (MSUD) about their disease and nutrition related issues in a camp environment. It will also look at pregnancy outcome results in women with PKU who attended Metabolic Camp and compare their results to other women with PKU who have not attended the Metabolic Camp.
Detailed Description
Study Phase N/A
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Pregnancy Phenylketonuria
Intervention † BehavioralMetabolic camp
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Behavioral
Estimated Enrollment † 35
Start Date † June 1995
Completion Date June 2000
Primary Completion Date June 2000
Eligibility Criteria † Inclusion Criteria: - Diagnosed with PKU, female, age 12 or older, able to provide informed consent Exclusion Criteria: - Those not fitting the inclusion criteria
Gender Female
Ages 12 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT01659749
Organization ID IRB00002447a
Secondary IDs †† NIH NCRR M01-RR00039
Responsible Party Principal Investigator
Study Sponsor † Emory University
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date December 2013
First Received Date † August 6, 2012
Last Updated Date December 5, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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