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:

ClinicalTrials.gov Identifier:

NCT01659749

First Posted: August 8, 2012

Last Update Posted: December 11, 2015

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Information provided by (Responsible Party):

Rani Singh, Emory University

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: 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).

Resource links provided by NLM:

Genetics Home Reference related topics: maple syrup urine disease phenylketonuria tetrahydrobiopterin deficiency

MedlinePlus related topics: Phenylketonuria

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

U.S. FDA Resources

Further study details as provided by Rani Singh, 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

Information from the National Library of Medicine

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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

Contacts and Locations

No Contacts or Locations Provided

More Information


Responsible Party:	Rani Singh, Professor, Emory University
ClinicalTrials.gov Identifier:	NCT01659749 History of Changes
Other Study ID Numbers:	IRB00002447a NIH NCRR M01-RR00039
First Submitted:	August 6, 2012
First Posted:	August 8, 2012
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

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