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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 (Project SIBS)

2026년 9월 28일 업데이트: Jason Paolo H. Labrador, Food and Nutrition Research Institute, Philippines

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 compelling impetus to gain further understanding on these aspects, particularly at the earliest stages of growth and development. However, previous studies in the Philippines that have specifically focused on the nutritional needs of pediatric patients with IEIPM are scarce. Therefore, this underscores the imperative need to carry out thorough evaluation of the nutritional characteristics of Filipino neonates, infants, children, and adolescents who have been diagnosed with IEIPM.

This study will provide information on nutritional status among pediatric patients with IEIPM in the local setting. The results will form a potential basis for incorporating rare diseases in the comprehensive nutrition program at the local government units focusing on the targeted special needs of this vulnerable group. The data on the dietary intakes will provide clinicians a better picture of the overall nutritional intake and the specific nutrients that may be lacking for optimal growth and development of infants and children under a restricted special diet. Moreover, this may also provide an opportunity to evaluate the adapted nutritional management guidelines being implemented in the continuity clinics in the country. Lastlly, the knowledge that will be generated will lead to a better understanding of the relationship between nutritional status, body composition, dietary intake, and some of the important biochemical and clinical outcomes that can guide the development of appropriate nutrition policies, guidelines tailored to fit the Filipino pediatric population with IEIPM. This study on IEIPM which covers amino acid disorders, organic acidemias, and urea cycle defects, recognizes the crucial role of research in defining health programs and activities for these rare conditions in support of the Republic Act no. 10747, also known as the Rare Diseases Act of the Philippines.

연구 개요

상태

모병

정황

상세 설명

The general objective of the study is to evaluate the nutritional status, growth, body composition, selected biochemical and clinical parameters, and dietary intakes of Filipino pediatric patients, aged 0 months-18 years old, diagnosed with Inborn Errors of Intermediary Protein Metabolism (IEIPM) who are receiving medical and dietary treatment. Specifically, the study aims to:

To compare the changes in nutritional status, body composition, dietary intake, selected biochemical, clinical parameters such as medical history and clinical presentations, anthropometric parameters such as height/length, weight and head circumference of pediatric patients diagnosed with IEIPM versus their age- and sex-matched healthy controls from baseline (month 0) to endline (month 12) assessment;
To assess the adequacy and distribution of energy, macro-and micronutrient intake from natural food, medical food, and combination of natural and medical food consumption of pediatric patients diagnosed with IEIPM from baseline (month 0) to endline (month 12) assessment;
To determine the association between nutritional status and body composition with dietary intakes, selected biochemical and clinical parameters;
To determine a safe protein-energy ratio (P:E ratio) associated with optimal nutritional status, growth, and body composition among Filipino pediatric patients with IEIPM; and
To determine caregivers' experiences, perceptions, and practices related to the dietary management of Maple Syrup Urine Disease (MSUD).

연구 유형

관찰

등록 (추정된)

176

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Jason Paolo H. Labrador, RND, MSPH
전화번호: local 308 8837-8113
이메일: jasonpaolo.labrador@fnri.dost.gov.ph

연구 연락처 백업

이름: Ebner Bon G. Maceda, MD, FPPS
전화번호: 63 2 8526-1725
이메일: egmaceda@up.edu.ph

연구 장소

필리핀 제도
- Batangas
  - Batangas, Batangas, 필리핀 제도, 4200
    - 아직 모집하지 않음
    - Batangas Medical Center
    - 연락하다:
      
      Carolyn I. Boongaling, MD, FPPS, FPSPME
      
      전화번호: (043) 740 8307
      
      이메일: krolbongga@gmail.com
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 수석 연구원:
      
      Carolyn I. Boongaling, MD, FPPS, FPSPME
- Bulacan
  - Malolos, Bulacan, 필리핀 제도, 3000
    - 모병
    - Bulacan Medical Center
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Ebner Bon G. Maceda, MD, FPPS
      
      전화번호: 63 2 8526-1725
      
      이메일: egmaceda@up.edu.ph
    - 수석 연구원:
      
      Jason Paolo H. Labrador, RND, MSPH
- Cavite
  - Trece Martires, Cavite, 필리핀 제도, 4109
    - 모병
    - General Emilio Aguinaldo Memorial Hospital
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
      
      전화번호: (046) 419 1716
      
      이메일: laguinaldo@up.edu.ph
    - 수석 연구원:
      
      Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
- Cebu
  - Cebu, Cebu, 필리핀 제도, 6000
    - 아직 모집하지 않음
    - Vicente Sotto Memorial Medical Center
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Ma. Rita Anna S. Boligao, MD, FPPS
      
      전화번호: (032) 253 9891
      
      이메일: mrboligao@up.edu.ph
    - 수석 연구원:
      
      Ma. Rita Anna S. Boligao, MD, FPPS
- Laguna
  - Calamba, Laguna, 필리핀 제도, 4027
    - 모병
    - Dr. Jose P. Rizal Memorial District Hospital
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Ebner Bon G. Maceda, MD, FPPS
      
      전화번호: 63 2 8526-1725
      
      이메일: egmaceda@up.edu.ph
    - 수석 연구원:
      
      Jason Paolo H. Labrador, RND, MSPH
- Manila
  - Manila, Manila, 필리핀 제도, 1000
    - 모병
    - University of the Philippines, Philippine General Hospital
    - 연락하다:
      
      Ebner Bon G. Maceda, MD, FPPS
      
      전화번호: 63 2 8526-1725
      
      이메일: egmaceda@up.edu.ph
    - 연락하다:
      
      Kevina Mariz M. Dajoyag, RN, MSGC
      
      전화번호: 63 2 8526-1725
      
      이메일: kmdajoyag@up.edu.ph
    - 수석 연구원:
      
      Ebner Bon G. Maceda, MD, FPPS
    - 부수사관:
      
      Kevina Mariz M. Dajoyag, RN, MSGC
- Misamis Oriental
  - Cagayan de Oro, Misamis Oriental, 필리핀 제도, 9000
    - 모병
    - Northern Mindanao Medical Center
    - 연락하다:
      
      Celenia-Jo S. Cagata, MD, FPPS
      
      전화번호: (088) 856-5490
      
      이메일: celeniacagata.md@gmail.com
    - 연락하다:
      
      Hezel F. Jurial, MD, DPPS
      
      전화번호: (088) 856-5490
      
      이메일: hfjurial@up.edu.ph
    - 수석 연구원:
      
      Celenia-Jo S. Cagata, MD, DPPS
    - 부수사관:
      
      Hezel F. Jurial, MD, DPPS
- National Capital Region
  - City of Taguig, National Capital Region, 필리핀 제도, 1633
    - 아직 모집하지 않음
    - Taguig City Health Centers
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 수석 연구원:
      
      Jason Paolo H. Labrador, RND, MSPH
    - 연락하다:
      
      Alexandra Lyne E. David, RND
      
      전화번호: local 308 8837-8113
      
      이메일: alexandralyneedavid@gmail.com
  - Paranaque City, National Capital Region, 필리핀 제도, 1711
    - 모병
    - Parañaque Health Centers
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 수석 연구원:
      
      Jason Paolo H. Labrador, RND, MSPH
    - 연락하다:
      
      Alexandra Lyne E. David, RND
      
      전화번호: local 308 8837-8113
      
      이메일: alexandralyneedavid@gmail.com
  - Pateros, National Capital Region, 필리핀 제도, 1620
    - 모병
    - Pateros Health Centers
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 수석 연구원:
      
      Jason Paolo H. Labrador, RND, MSPH
    - 연락하다:
      
      Alexandra Lyne E. David, RND
      
      전화번호: local 308 8837-8113
      
      이메일: alexandralyneedavid@gmail.com
  - Quezon City, National Capital Region, 필리핀 제도, 1105
    - 아직 모집하지 않음
    - Philippine Children's Medical Center
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Teresa B. Bangcaya, MD, DPPS
      
      전화번호: (02) 8588-9900
      
      이메일: teresabangcaya@gmail.com
    - 수석 연구원:
      
      Teresa B. Bangcaya, MD, DPPS
- Nueva Ecija
  - Cabanatuan City, Nueva Ecija, 필리핀 제도, 3100
    - 모병
    - Dr. Paulino J. Garcia Memorial Research and Medical Center
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Leah Mae C. Besa, MD
      
      전화번호: (044) 463 8888
      
      이메일: leahmaecruzmd@gmail.com
    - 수석 연구원:
      
      Leah Mae C. Besa, MD
- Pampanga
  - San Fernando City, Pampanga, 필리핀 제도, 2000
    - 모병
    - Jose B. Lingad Memorial General Hospital
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
      
      전화번호: (045) 409-6688
      
      이메일: viani_10@yahoo.com
    - 수석 연구원:
      
      Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
- Quezon
  - Lucena City, Quezon, 필리핀 제도, 4301
    - 모병
    - Quezon Medical Center
    - 연락하다:
      
      Jason Paolo H. Labrador, RND, MSPH
      
      전화번호: local 308 8837-8113
      
      이메일: jasonpaolo.labrador@fnri.dost.gov.ph
    - 연락하다:
      
      Josephine Leiya Marie F. Salud-Masanga, MD, FPPS, FPSPME
      
      전화번호: (042) 717 6323
      
      이메일: drsaludmasangaclinic@gmail.com
    - 수석 연구원:
      
      Josephine Leiya Marie F. Salud-Masanga, MD, FPPS, FPSPME

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1초 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

The study will involve 140 Filipino pediatric patients with IEIPM from the identified eleven (11) Newborn Screening Continuity Clinics (NBSCC) from NCR, Region III, IV-A, VII, and X. The 36 age- and sex-matched controls will be recruited from the health centers of Taguig, Pateros, and Parañaque in Metro Manila.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
IEIPM patients Eligible pediatric patients diagnosed with Inborn Errors of Intermediary Protein Metabolism
Age- and sex-matched healthy controls Free-living age- and sex-matched healthy children

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Weight (in kilograms) and age (in years and months) will be combined to report Weight-for-Age in Z-score 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	Weight will be measured using a digital baby weighing scale (SECA 354) for children younger than 2 years of age and a double-window digital weighing scale (SECA 874) for children older than 2 years of age. This indicator will be used in children aged 0-10 years. The z-scores will be obtained using the World Health Organization (WHO) Child Growth Standards 2006 and Growth Reference 2007 to determine if the child is normal (-2SD to +2SD), underweight (<-2SD), or severely underweight (<-3SD).	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Height/Length (in centimeters) and age (in years and months) will be combined to report Height/Length-for-Age in Z-score 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	Height/length will be measured using an infantometer (SECA 416/417) for children younger than 2 years of age and a stadiometer (SECA 213 I) for children older than 2 years of age. The z-scores will be obtained using the WHO Child Growth Standards 2006 and Growth Reference 2007 to determine if the child is normal (-2SD to +2SD), stunted (<-2SD), or severely stunted (<-3SD).	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Weight (in kilograms) and height (in centimeters) will be combined to report Weight-for-Height in Z-score 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	This indicator will be used in children aged 0-5 years. The z-scores will be obtained using the WHO Child Growth Standards 2006 to determine if the child is severely wasted (<-3SD), wasted (<-2SD), normal (-2SD to +2SD), overweight (>+2SD), or obese (>+3SD).	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Weight (in kilograms), height (in meters), and age (in years and months) will be combined to report BMI-for-Age in Z-score 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	Body Mass Index (BMI) will be calculated based on weight and height (kg/m²). The z-scores will be obtained using the WHO Growth Reference 2007 to determine if the child is severely wasted (<-3SD), wasted (<-2SD), normal (-2SD to +2SD), overweight (>+2SD), or obese (>+3SD).	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Head circumference (in centimeters) and age (in years and months) will be combined to report Head circumference-for-Age in Z-score 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	Head circumference will be measured using a calibrated measuring tape (SECA 212). The z-scores will be obtained using the WHO Child Growth Standards 2006 to determine if the child presented with microcephaly (>-2SD), normal (-2SD to +2SD), or macrocephaly (>+2SD).	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Fat Mass in percentage and in kilograms 기간: Month 0 (Baseline) and Month 12 (Endline)	Fat mass will be measured through a Dual-Energy X-ray Absorptiometry scan using the GE Lunar Prodigy model. The values will be analyzed using Hologic Apex Software following the manufacturer's guidelines.	Month 0 (Baseline) and Month 12 (Endline)
Lean Mass in kilograms 기간: Month 0 (Baseline) and Month 12 (Endline)	Lean mass will be assessed through a Dual-Energy X-ray Absorptiometry scan using the GE Lunar Prodigy model. The values will be analyzed using Hologic Apex Software following the manufacturer's guidelines.	Month 0 (Baseline) and Month 12 (Endline)
Bone Mineral Density (BMD) in g/cm² 기간: Month 0 (Baseline) and Month 12 (Endline)	Bone mineral density will be assessed through a Dual-Energy X-ray Absorptiometry scan using the GE Lunar Prodigy model. The values will be analyzed using Hologic Apex Software following the manufacturer's guidelines.	Month 0 (Baseline) and Month 12 (Endline)
Mean Dietary Intake in kilocalories and grams per day 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	Dietary intake will be obtained using a 3-day non-consecutive food record (two weekdays and one weekend). This will be assessed using the Philippine Food Composition Tables (PhilFCT), the US FDA, and other available databases. Mean intake of energy, macro-, and micronutrients will be reported.	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Diet Adequacy in percentage 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	The adequacy of intakes will be assessed by calculating the Energy/ Nutrient Adequacy Ratio and recommended requirements will be derived from the condition-specific recommended nutrient intake by the Southeast Regional Genetics Network-Genetic Metabolic Dietitians International, WHO Guidelines, and Philippine Dietary Reference Intakes (2015).	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Protein-to-Energy Ratio (P:E Ratio) in grams protein/100 kilocalories/ day 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	The P:E ratio expressed will be derived from participants' dietary intake data and compared with the P:E ratio calculated from the 1985 FAO/WHO/UNU equation.	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

2차 결과 측정

결과 측정	측정값 설명	기간
Plasma Amino Acid concentration in umol/L 기간: Month 0 (Baseline) and Month 12 (Endline)	Levels of free amino acids in the blood plasma will be quantitatively measured. Three (3) mL of whole blood in sodium heparin will be obtained through venipuncture.	Month 0 (Baseline) and Month 12 (Endline)
Anemia (Low hemoglobin concentration in g/dL) 기간: Month 0 (Baseline) and Month 12 (Endline)	The amount of whole blood in Ethylenediaminetetraacetic acid (EDTA) obtained through venipuncture or finger prick that will be used for analysis is 0.5 mL. To be identified if anemia is present in an individual, hemoglobin levels are low. The values should be below the normal results of the following based on age and sex: 11.0 g/dL for children aged 6 months to 6 years old,12.0 g/dL for 6 to 14 years old,13.0 g/dL for males 15 years old and above, and 12.0 g/dL for females 15 years old and above.	Month 0 (Baseline) and Month 12 (Endline)
Serum Vitamin A concentration in µg/dL 기간: Month 0 (Baseline) and Month 12 (Endline)	The amount of serum from clotted whole blood obtained through venipuncture that will be used for analysis is 0.5 mL. Retinol values will be considered high if results of participants are greater than 50 µg/dL.	Month 0 (Baseline) and Month 12 (Endline)
Serum 25-hydroxyvitamin D concentration in nmol/L 기간: Month 0 (Baseline) and Month 12 (Endline)	The amount of serum from clotted whole blood that will be used for analysis is 0.3 mL. Normal vitamin D levels lie between the values of 75.0-100.0 nmol/L. Results of 74.0 nmol/L and below are considered deficient, while 101.0 nmol/L and above are considered elevated.	Month 0 (Baseline) and Month 12 (Endline)
Serum Vitamin B12 concentration in pmol/L 기간: Month 0 (Baseline) and Month 12 (Endline)	The amount of serum from clotted whole blood obtained from venipuncture that will be used for analysis is 0.3 mL. Vitamin B12 values are increased when results are above 652 pmol/L.	Month 0 (Baseline) and Month 12 (Endline)
Serum Zinc concentration in µg/dL 기간: Month 0 (Baseline) and Month 12 (Endline)	The amount of serum from clotted whole blood obtained through venipuncture that will be used for analysis is 0.5 mL. Normal values of zinc are grouped physiologically and by the time of sample extraction, considering also whether the individual fasted or not. For children aged 10 and below, non-fasting samples are extracted, and results showing concentrations below 65 µg/dL (AM) and 57 µg/dL (PM) are considered deficient. For females aged more than 10 years, results showing concentrations of zinc in the fasting sample below 70 µg/dL and in the non-fasting sample with results below 66 µg/dL(AM) and 59 µg/dL (PM) are considered deficient. For males aged more than 10 years, results showing concentrations of zinc in fasting samples below 74 µg/dL, non-fasting samples with results below 70 µg/dL(AM), and 61 µg/dL (PM) are considered deficient.	Month 0 (Baseline) and Month 12 (Endline)
Serum Folic Acid concentration in nmol/L 기간: Month 0 (Baseline) and Month 12 (Endline)	Levels of folic acid are measured quantitatively. The amount of serum from clotted whole blood obtained by venipuncture that will be used for analysis is 0.3 mL.	Month 0 (Baseline) and Month 12 (Endline)
Overall Risk of Malnutrition 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	The overall risk of malnutrition will be evaluated using the Pediatric Subjective Global Nutritional Assessment (PSGNA) Form. The PSGNA is used to subjectively assess the nutritional status of children who may be at risk of malnutrition through a nutrition-focused physical exam. Loss of subcutaneous fat will be checked in the orbital, buccal area, upper arm, ribs/midaxillary, and buttocks. Loss of muscle mass in the temple region, clavicle bone, acromion bone, scapular bone and spine regions, anterior thigh, patellar, and calf will be assessed. Lastly, the presence of edema will also be evaluated in the foot, ankles, and sacral area. The classification to determine the risk of malnutrition is as follows: Normal/Well-nourished: No loss of subcutaneous fat and muscle mass, and no edema Moderate risk: Loss of subcutaneous fat and muscle mass is observed in at least one area, and/or with edema Severe risk: Loss of subcutaneous fat and muscle mass is observed in more than one area,	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

기타 결과 측정

결과 측정	측정값 설명	기간
Mean Age at Diagnosis of IEIPM Participants in years and months 기간: Month 0 (Baseline)	The mean age at diagnosis will be based on the medical chart of the participant kept in the NBSCCs. This will be recorded in the medical chart extraction form.	Month 0 (Baseline)
Mean Age at Onset of Symptoms of IEIPM Participants in years and months 기간: Month 0 (Baseline)	The mean age at onset of symptoms will be based on the medical chart of the participant kept in the NBSCCs. This will be recorded in the medical chart extraction form.	Month 0 (Baseline)
Mean Age at Initiation of Treatment of IEIPM Participants in years and months 기간: Month 0 (Baseline)	The mean age at the initiation of treatment will be based on the medical chart of the participant kept in the NBSCCs. This will be recorded in the medical chart extraction form.	Month 0 (Baseline)
Proportion of IEIPM Participants with a History of Inborn Errors of Metabolism (IEM) in the Family (in percentage) 기간: Month 0 (Baseline)	The history of IEM in the family will be based on the medical chart of the participant kept in the NBSCCs. This will be recorded in the medical chart extraction form.	Month 0 (Baseline)
Current Treatments of IEIPM Participants 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	The current treatment will be based on the medical chart of the participant kept in the NBSCCs. This will be recorded in the medical chart extraction form.	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)
Proportion of IEIPM Participants with Clinical Presentations (in percentage) 기간: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)	The presence of clinical presentations will be based on the latest available developmental assessment of the patients by their respective attending metabolic physician recorded in the medical charts kept in the NBSCCs. The clinical presentations to be documented include developmental delay/ intellectual disability, speech delay, seizures, long tract signs, hypotonia, no visual threat/dazzle, hyperactivity, microcephaly, drooling, esotropia, no reaction to sound, jitteriness, weakness, spasticity, quadriparesis, and others. This will be recorded in the medical chart extraction form.	Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Food and Nutrition Research Institute, Philippines

협력자

Philippine Council for Health Research & Development

University of the Philippines Manila - Philippine General Hospital

Northern Mindanao Medical Center, Cagayan de Oro City

Vicente Sotto Memorial Medical Center

Philippine Children's Medical Center

수사관

수석 연구원: Jason Paolo H. Labrador, RND, MSPH, Department of Science and Technology - Food and Nutrition Research Institute
수석 연구원: Ebner Bon G. Maceda, MD, FPPS, University of the Philippines Manila - Institute of Human Genetics

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

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2028년 3월 1일

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2026년 9월 9일

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2026년 9월 23일

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추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

DOH SJREB 2026-20

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

An Evaluation of Nutritional Status, Body Composition, and Dietary Intakes of Filipino Pediatric Patients With Inborn Errors of Intermediary Protein Metabolism (Project SIBS)

연구 개요

상태

정황

상세 설명

연구 유형

등록 (추정된)

연락처 및 위치

연구 연락처

연구 연락처 백업

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

샘플링 방법

연구 인구

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

기타 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

협력자

수사관

간행물 및 유용한 링크

일반 간행물

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

약물 및 장치 정보, 연구 문서

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