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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age11+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed with PKU or other aminoacidopathy, female, age 11 or older, able to provide informed consent

Disqualifiers

Those not fitting the inclusion criteria

Adult camp counselors or staff determined to be in good health.

Not diagnosed with PKU, MSUD or other hereditary metabolic disorder

Willing and able to provide written informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Metabolic camp

    Behavioral

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Metabolic CampOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in plasma Amino Acid concentration

Concentration of Phenylalanine in plasma (measured in mg/dL) will be measured the first day of metabolic camp and at the last day of the camp.

Time frame
Baseline, Week 1
2

Change in Dietary intake of Phenylalanine

Dietary intake of Phenylalanine (measured in mg/Kg) will be measured the first day of metabolic camp and at the last day of the camp, using a three-day diet food record that has been completed at baseline and post-camp.

Time frame
Baseline, Week 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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