Nutritional Status and Body Composition in Filipino Children with Inborn Errors of Metabolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will evaluate the nutritional status, growth measures, body composition, biochemical and clinical parameters, and dietary intakes of Filipino pediatric patients with inborn errors of intermediary protein metabolism (IEIPM) who are receiving treatment. It will compare baseline data with endline data at 12 months and contrast patients with age- and sex-matched healthy controls. The study will analyze energy and nutrient intake from natural foods, medical foods, and combinations thereof, and explore associations between nutrition, body composition, and clinical markers. It also aims to identify a safe protein-energy ratio and to understand caregiver experiences and practices related to dietary management. The findings could inform nutritional care strategies and family guidance for IEIPM in similar settings.

Why it matters

Who can join: the full rules

IEIPM PATIENTS

Inclusion Criteria

* Confirmed to have Amino Acid Disorders, Organic Acidurias, and Urea Cycle Defects by newborn screening or by biochemical testing in urine or plasma
* Included in the metabolic registry of the Institute of Human Genetics-National Institutes of Health (IHG-NIH) and seen at the identified Newborn Screening Continuity Clinics (study sites)
* With at least one (1) month of active medical treatment and/or with regular follow-up
* The participant/parent/guardian or any legally acceptable representative consented to participate in the study

Exclusion Criteria

* With co-existing conditions not part of IEIPM and its complications (i.e. multiple congenital anomalies, hypoxic-ischemic encephalopathy, central brain abnormalities, any diagnosed systematic organic illness (e.g., renal, heart, or thyroid disease) or any suspected acute metabolic conditions other than IEIPM;
* Currently enrolled in other research studies with intervention study design

AGE- AND SEX-MATCHED HEALTHY CONTROLS

Inclusion Criteria

* Apparently healthy children, ages 0 month to 18 years and 364 days old at the time of the study recruitment;
* Without any diagnosed genetic and/or metabolic disorders
* With normal nutritional status (based on WHO CGS and Growth Reference 2007)
* The participant/parent/guardian or any legally acceptable representative consented to participate in the study

Exclusion Criteria

* Diagnosed with any genetic and/or metabolic disorders
* With any chronic illnesses known to affect growth and nutritional status
* Currently enrolled in other research studies with intervention study design

Where it's running

• Bulacan Medical Center
  Malolos, Bulacan, Philippines Recruiting
• General Emilio Aguinaldo Memorial Hospital
  Trece Martires, Cavite, Philippines Recruiting
• Dr. Jose P. Rizal Memorial District Hospital
  Calamba, Laguna, Philippines Recruiting
• University of the Philippines, Philippine General Hospital
  Manila, Manila, Philippines Recruiting
• Northern Mindanao Medical Center
  Cagayan de Oro, Misamis Oriental, Philippines Recruiting
• Parañaque Health Centers
  Paranaque City, National Capital Region, Philippines Recruiting

Study contacts

• Principal investigator: Jason Paolo H. Labrador, RND, MSPH — Department of Science and Technology - Food and Nutrition Research Institute
• Study coordinator: Jason Paolo H. Labrador, RND, MSPH
• Email: jasonpaolo.labrador@fnri.dost.gov.ph
• Phone: 8837-8113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.