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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dawn Laney, MS, CCRC, Emory University

ClinicalTrials.gov Identifier:

NCT01659749

First received: August 6, 2012

Last updated: December 5, 2013

Last verified: December 2013

History of Changes

Purpose

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	Intervention
Pregnancy Phenylketonuria	Behavioral: Metabolic camp


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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).

Resource links provided by NLM:

Genetics Home Reference related topics: argininosuccinic aciduria citrullinemia maple syrup urine disease N-acetylglutamate synthase deficiency ornithine translocase deficiency phenylketonuria succinic semialdehyde dehydrogenase deficiency tetrahydrobiopterin deficiency

MedlinePlus related topics: Phenylketonuria

Genetic and Rare Diseases Information Center resources: Inborn Amino Acid Metabolism Disorder Maple Syrup Urine Disease Phenylketonuria

U.S. FDA Resources

Further study details as provided by Emory University:


Enrollment:	35
Study Start Date:	June 1995
Study Completion Date:	June 2000
Primary Completion Date:	June 2000 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility


Ages Eligible for Study:	12 Years and older
Genders 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Dawn Laney, MS, CCRC, Instructor, Emory University
ClinicalTrials.gov Identifier:	NCT01659749 History of Changes
Other Study ID Numbers:	IRB00002447a, NIH NCRR M01-RR00039
Study First Received:	August 6, 2012
Last Updated:	December 5, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Emory University:


Genetics Metabolic Nutrition Maternal PKU Phenylketonuria (PKU)

Additional relevant MeSH terms:


Phenylketonurias Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn	Central Nervous System Diseases Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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