Educational and nutritional support for women with Phenylketonuria during pregnancy
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).
This study tests whether a special camp that offers education and support can help women with PKU or MSUD have healthier pregnancies and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 11 Years and up |
| Sex | Female |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT01659749 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of an educational and social support program, known as Metabolic Camp, for teen and adult women diagnosed with Phenylketonuria (PKU) or Maple Syrup Urine Disease (MSUD). The camp provides a supportive environment where participants learn about disease management and nutrition, with the goal of improving pregnancy outcomes and quality of life. The study will compare pregnancy outcomes of women who attended the camp with those who did not, assessing changes in knowledge, dietary compliance, and overall well-being. Data will be collected through a structured research protocol before and after the camp.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 11 and older diagnosed with Phenylketonuria or other related metabolic disorders.
Not a fit: Patients who do not have PKU, MSUD, or other hereditary metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve pregnancy outcomes and quality of life for women with PKU.
How similar studies have performed: Other studies have shown positive outcomes with educational interventions for metabolic disorders, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia
- Emory University Department of Human Genetics — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Rani H Singh, PhD RD — Emory University
- Study coordinator: Rani H Singh, PhD RD
- Email: rsingh@emory.edu
- Phone: 4047278519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.