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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Dietary intake of Phenylalanine

Change in plasma Amino Acid concentration

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

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Who is running the clinical trial?

Emory UniversityLead Sponsor

1,639 Previous Clinical Trials

2,560,446 Total Patients Enrolled

Rani H Singh, PhD RDPrincipal InvestigatorEmory University

Media Library

Metabolic Camp Clinical Trial Eligibility Overview. Trial Name: NCT01659749 — N/A

Phenylketonuria Research Study Groups: Metabolic Camp

Phenylketonuria Clinical Trial 2023: Metabolic Camp Highlights & Side Effects. Trial Name: NCT01659749 — N/A

Metabolic Camp 2023 Treatment Timeline for Medical Study. Trial Name: NCT01659749 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have committed to participating in this experiment?

"Affirmative. Clinicaltrials.gov indicates that the medical trial, which was first introduced on June 1st 1995, is in its recruitment stage and needs to enroll 200 patients at a single centre."

Answered by AI

Are there any available slots to join this clinical research?

"Affirmative. Details on clinicaltrials.gov indicate that this research trial, first published in June 1995, is currently recruiting participants. Approximately 200 patients need to be acquired at 1 site."

Answered by AI

Recent research and studies

Molecular Genetics and MetabolismJournal

Protein Intake and Physical Activity Are Associated with Body Composition in Individuals with Phenylalanine Hydroxylase Deficiency

Jani, Rati, Kathryn Coakley, Teresa Douglas, and Rani Singh. 2017. “Protein Intake and Physical Activity Are Associated with Body Composition in Individuals with Phenylalanine Hydroxylase Deficiency”. Molecular Genetics and Metabolism. Elsevier BV. doi:10.1016/j.ymgme.2017.04.012.

clinicaltrials.govStudy

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

Rani Singh 1995. "Educational, Social Support, and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01659749.

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