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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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ClinicalTrials.gov Identifier: NCT01659749
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Rani Singh, Emory University

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.

Condition or disease Intervention/treatment Phase
Pregnancy Phenylketonuria Behavioral: Metabolic camp Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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).
Study Start Date : June 1995
Actual Primary Completion Date : June 2000
Actual Study Completion Date : June 2000



Intervention Details:
    Behavioral: Metabolic camp
    To use an recreational camp setting to instruct PKU females of reproductive age how to make responsible dietary and reproductive decisions.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with PKU, female, age 12 or older, able to provide informed consent

Exclusion Criteria:

  • Those not fitting the inclusion criteria

Responsible Party: Rani Singh, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01659749     History of Changes
Other Study ID Numbers: IRB00002447a
NIH NCRR M01-RR00039
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by Rani Singh, Emory University:
Genetics
Metabolic
Nutrition
Maternal PKU
Phenylketonuria (PKU)

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