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Metabolic Camp for Pregnant Women with Phenylketonuria

N/A

Recruiting

Led By Rani H Singh, PhD RD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether teaching teens and young women with Phenylketonuria (PKU) or Maple Syrup Urine Disease (MSUD) about their disease and nutrition in a camp environment improves pregnancy outcomes.

Who is the study for?

This trial is for females aged 11 or older diagnosed with Phenylketonuria (PKU) or similar amino acid disorders, who can understand and agree to the study's terms. It includes adult camp counselors in good health willing to follow camp rules and study procedures.

What is being tested?

The effectiveness of an educational Metabolic Camp designed to teach teens and young women about PKU/MSUD and nutrition. The study will compare pregnancy outcomes between attendees of this camp and those with PKU who haven't attended.

What are the potential side effects?

Since the intervention involves education, social support, and nutritional guidance rather than medication, no direct medical side effects are expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman, 11 or older, with PKU or a similar condition, and can consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Dietary intake of Phenylalanine

Change in plasma Amino Acid concentration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Metabolic CampExperimental Treatment1 Intervention

Metabolic Camp is an educational and social support program for females age 11 through adult with phenylketonuria (PKU) and maple syrup urine disease (MSUD), two inherited metabolic disorders (IMD). Camp provides a supportive environment for adolescent girls and women to learn about the importance of nutrition and diet self-management, with the intention of arresting the disease process and minimizing the instances of miscarriages and severe birth defects, which are high in this population. After 20+ years, Metabolic Camp is established as a unique, national program allowing up to 35 campers to live and learn during a week of nutritional support and productive activities, while simultaneously providing researchers an opportunity to gather important data.

0 / 1Eligibility criteria met