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):

Dr. Singh H. Singh, Emory University

ClinicalTrials.gov Identifier:

NCT01659749

First received: August 6, 2012

Last updated: August 7, 2012

Last verified: August 2012

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 Urine and Urination

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Dr. Singh H. Singh, Associate Professor, Emory University
ClinicalTrials.gov Identifier:	NCT01659749 History of Changes
Other Study ID Numbers:	1007-2004, NIH NCRR M01-RR00039
Study First Received:	August 6, 2012
Last Updated:	August 7, 2012
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
Maple Syrup Urine Disease
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

ClinicalTrials.gov processed this record on June 13, 2013

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