RecruitingNot Applicable

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

United States200 participantsStarted 1995-06

Plain-language 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.

Who can participate

Age range

11 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with PKU or other aminoacidopathy, female, age 11 or older, able to provide informed consent Exclusion Criteria: * Those not fitting the inclusion criteria Inclusion Criteria for healthy controls Individuals eligible to participate in this study must meet all of the following 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 * Willing and able to comply with relevant camp guidelines and study procedures

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in plasma Amino Acid concentration

Timeframe: Baseline, Week 1

Change in Dietary intake of Phenylalanine

Timeframe: Baseline, Week 1

Trial details

NCT IDNCT01659749

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-07

Contact for this trial

Rani H Singh, PhD RD

4047278519 rsingh@emory.edu

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