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โ† Trials
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An Evaluation of Nutritional Status, Body Composition, and Dietary Intakes of Filipino Pediatric Patients With Inborn Errors of Intermediary Protein Metabolism

Recruitingn/aAges 0 Months - 18 YearsAllFood and Nutrition Research Institute, Philippines
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In plain words

What the trial is, and whether it could suit you

In the Philippines, a disease is considered rare if it affects one in every 20,000 individuals. About 75% of rare diseases in the country, including inborn errors of intermediary protein metabolism (IEIPM), are of genetic in origin with symptoms beginning in early infancy with about 30 percent of patients dying before the age of five. Diagnosing nutritional problems in pediatrics with IEIPM is challenging due to the potential absence or masking of early signs and symptoms. Nutrition care is more difficult to manage since dietary modification for these patients require extraordinary and diligent attention as an uncontrolled or poorly managed diet can lead to severe health conditions. Its detrimental effects are irreversible and might last until adulthood affecting the overall quality of life and well-being of the child and increasing the burden on parents and families. Hence, there is a c

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

14 sites
Batangas Medical Center
Batangas, Philippines
Bulacan Medical Center
Malolos, Philippines
General Emilio Aguinaldo Memorial Hospital
Trece Martires, Philippines
Vicente Sotto Memorial Medical Center
Cebu, Philippines
Dr. Jose P. Rizal Memorial District Hospital
Calamba, Philippines
University of the Philippines, Philippine General Hospital
Manila, Philippines
Northern Mindanao Medical Center
Cagayan de Oro, Philippines
Taguig City Health Centers
City of Taguig, Philippines

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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