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Metabolism, Inborn ErrorsProject SIBSNCT07837336

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

An observational study of Metabolism, Inborn Errors and Amino Acid Metabolism, Inborn Errors, run by Food and Nutrition Research Institute, Philippines at 14 sites in Philippines.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 0 months to 18 yearsHealthy volunteers can take part
How many people
176 participants
Where
14 sitesPhilippines
Study dates
10 Mar 2026to Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 months to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: 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.

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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
  • 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

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jason Paolo H. Labrador, RND, MSPH contact

8837-8113 ext. local 308

jasonpaolo.labrador@fnri.dost.gov.ph

Ebner Bon G. Maceda, MD, FPPS contact

63 2 8526-1725

egmaceda@up.edu.ph

14 sites in 1 country

Philippines14 sites, 14 recruiting

  • Batangas Medical Center

    Batangas, Batangas, 4200

    Carolyn I. Boongaling, MD, FPPS, FPSPME, (043) 740 8307, krolbongga@gmail.com

    Jason Paolo H. Labrador, RND, MSPH, 8837-8113, jasonpaolo.labrador@fnri.dost.gov.ph

    Not yet recruiting

  • Dr. Paulino J. Garcia Memorial Research and Medical Center

    Cabanatuan City, Nueva Ecija, 3100

    Leah Mae C. Besa, MD, (044) 463 8888, leahmaecruzmd@gmail.com

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

    Recruiting

  • Northern Mindanao Medical Center

    Cagayan de Oro, Misamis Oriental, 9000

    Celenia-Jo S. Cagata, MD, FPPS, (088) 856-5490, celeniacagata.md@gmail.com

    Hezel F. Jurial, MD, DPPS, (088) 856-5490, hfjurial@up.edu.ph

    Recruiting

  • Dr. Jose P. Rizal Memorial District Hospital

    Calamba, Laguna, 4027

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

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

    Recruiting

  • Vicente Sotto Memorial Medical Center

    Cebu, Cebu, 6000

    Ma. Rita Anna S. Boligao, MD, FPPS, (032) 253 9891, mrboligao@up.edu.ph

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

    Not yet recruiting

  • Taguig City Health Centers

    City of Taguig, National Capital Region, 1633

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

    Alexandra Lyne E. David, RND, 8837-8113 ext. local 308, alexandralyneedavid@gmail.com

    Not yet recruiting

  • Quezon Medical Center

    Lucena City, Quezon, 4301

    Josephine Leiya Marie F. Salud-Masanga, MD, FPPS, FPSPME, (042) 717 6323, drsaludmasangaclinic@gmail.com

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

    Recruiting

  • Bulacan Medical Center

    Malolos, Bulacan, 3000

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

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

    Recruiting

  • University of the Philippines, Philippine General Hospital

    Manila, Manila, 1000

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

    Kevina Mariz M. Dajoyag, RN, MSGC, 63 2 8526-1725, kmdajoyag@up.edu.ph

    Recruiting

  • Parañaque Health Centers

    Paranaque City, National Capital Region, 1711

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

    Alexandra Lyne E. David, RND, 8837-8113 ext. local 308, alexandralyneedavid@gmail.com

    Recruiting

  • Pateros Health Centers

    Pateros, National Capital Region, 1620

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

    Alexandra Lyne E. David, RND, 8837-8113 ext. local 308, alexandralyneedavid@gmail.com

    Recruiting

  • Philippine Children's Medical Center

    Quezon City, National Capital Region, 1105

    Teresa B. Bangcaya, MD, DPPS, (02) 8588-9900, teresabangcaya@gmail.com

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

    Not yet recruiting

  • Jose B. Lingad Memorial General Hospital

    San Fernando City, Pampanga, 2000

    Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP, (045) 409-6688, viani_10@yahoo.com

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

    Recruiting

  • General Emilio Aguinaldo Memorial Hospital

    Trece Martires, Cavite, 4109

    Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc, (046) 419 1716, laguinaldo@up.edu.ph

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

    Recruiting

Other trials in Philippines

About this study

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.

Read the detailed description

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:

  1. 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;
  2. 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;
  3. To determine the association between nutritional status and body composition with dietary intakes, selected biochemical and clinical parameters;
  4. 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
  5. To determine caregivers' experiences, perceptions, and practices related to the dietary management of Maple Syrup Urine Disease (MSUD).
Keywords
Metabolism, Inborn Errors, Amino Acid Metabolism, Inborn Errors, Nutritional Status, Dietary Intake, Filipino Pediatric Patients
Medical subject headings
Metabolism, Inborn Errors, Amino Acid Metabolism, Inborn Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07837336
Study groupRoleWhat they receive
IEIPM patientsEligible pediatric patients diagnosed with Inborn Errors of Intermediary Protein Metabolism
Age- and sex-matched healthy controlsFree-living age- and sex-matched healthy children

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight (in kilograms) and age (in years and months) will be combined to report Weight-for-Age in Z-score

    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).

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

  2. Height/Length (in centimeters) and age (in years and months) will be combined to report Height/Length-for-Age in Z-score

    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).

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

  3. Weight (in kilograms) and height (in centimeters) will be combined to report Weight-for-Height in Z-score

    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).

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

  4. Weight (in kilograms), height (in meters), and age (in years and months) will be combined to report BMI-for-Age in Z-score

    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).

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

  5. Head circumference (in centimeters) and age (in years and months) will be combined to report Head circumference-for-Age in Z-score

    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).

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

  6. Fat Mass in percentage and in kilograms

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  7. Lean Mass in kilograms

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  8. Bone Mineral Density (BMD) in g/cm²

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  9. Mean Dietary Intake in kilocalories and grams per day

    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.

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

  10. Diet Adequacy in percentage

    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).

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

  11. Protein-to-Energy Ratio (P:E Ratio) in grams protein/100 kilocalories/ day

    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.

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

Secondary outcomes (8)

  1. Plasma Amino Acid concentration in umol/L

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  2. Anemia (Low hemoglobin concentration in g/dL)

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  3. Serum Vitamin A concentration in µg/dL

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  4. Serum 25-hydroxyvitamin D concentration in nmol/L

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  5. Serum Vitamin B12 concentration in pmol/L

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  6. Serum Zinc concentration in µg/dL

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  7. Serum Folic Acid concentration in nmol/L

    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.

    Measured: Month 0 (Baseline) and Month 12 (Endline)

  8. Overall Risk of Malnutrition

    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,

    Measured: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study start10 Mar 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07837336
Sponsor's protocol ID
DOH SJREB 2026-20
Acronym
Project SIBS
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Philippine Health Research Ethics Board. National ethical guidelines for research involving human participants 2022. Manila: Department of Science and Technology - Philippine Council for Health Research and Development; 2022

  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

    PubMed 24141714

  • NACB LMPG Committee Members; Myers GL, Christenson RH, Cushman M, Ballantyne CM, Cooper GR, Pfeiffer CM, Grundy SM, Labarthe DR, Levy D, Rifai N, Wilson PW. National Academy of Clinical Biochemistry Laboratory Medicine Practice guidelines: emerging biomarkers for primary prevention of cardiovascular disease. Clin Chem. 2009 Feb;55(2):378-84. doi: 10.1373/clinchem.2008.115899. Epub 2008 Dec 23.

    PubMed 19106185

  • Department of Science and Technology - Food and Nutrition Research Institute. Philippine nutrition facts and figures 2015: updating of nutritional status of Filipino children and other population groups overview. Taguig City: DOST-FNRI; 2016.

  • Department of Science and Technology - Food and Nutrition Research Institute. Philippine nutrition facts and figures 2013: biochemical survey. 2nd ed. Taguig City: FNRI-DOST; 2015.

  • Department of Science and Technology - Food and Nutrition Research Institute. Philippine Dietary Reference Intakes. Bicutan, Taguig City: DOST-FNRI; 2015.

  • World Health Organization. Healthy diet. Geneva: World Health Organization; 2020 Apr 19. Available from: https://www.who.int/news-room/fact-sheets/detail/healthy-diet

  • Southeast Regional Genetics Network, Genetic Metabolic Dietitians International. Nutrition Management Guidelines. SERN/GMDI; 2013. Available from: https://managementguidelines.net/

  • de Onis M, Onyango AW, Borghi E, Siyam A, Nishida C, Siekmann J. Development of a WHO growth reference for school-aged children and adolescents. Bull World Health Organ. 2007 Sep;85(9):660-7. doi: 10.2471/blt.07.043497.

    PubMed 18026621

  • World Health Organization. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development. Geneva: World Health Organization; 2006.

  • Peplow C, Assfalg R, Beyerlein A, Hasford J, Bonifacio E, Ziegler AG. Blood draws up to 3% of blood volume in clinical trials are safe in children. Acta Paediatr. 2019 May;108(5):940-944. doi: 10.1111/apa.14607. Epub 2018 Oct 30.

    PubMed 30291644

  • Howie SR. Blood sample volumes in child health research: review of safe limits. Bull World Health Organ. 2011 Jan 1;89(1):46-53. doi: 10.2471/BLT.10.080010. Epub 2010 Sep 10.

    PubMed 21346890

  • WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138650/

    PubMed 23741774

  • Kulkarni B, Mamidi RS, Balakrishna N, Radhakrishna KV. Body composition assessment in infancy and early childhood: comparison of anthropometry with dual-energy X-ray absorptiometry in low-income group children from India. Eur J Clin Nutr. 2014 Jun;68(6):658-63. doi: 10.1038/ejcn.2014.37. Epub 2014 Mar 19.

    PubMed 24642784

  • Wong MC, Ng BK, Kennedy SF, Hwaung P, Liu EY, Kelly NN, Pagano IS, Garber AK, Chow DC, Heymsfield SB, Shepherd JA. Children and Adolescents' Anthropometrics Body Composition from 3-D Optical Surface Scans. Obesity (Silver Spring). 2019 Nov;27(11):1738-1749. doi: 10.1002/oby.22637.

    PubMed 31689009

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolism, Inborn Errors and Amino Acid Metabolism, Inborn Errors, run by Food and Nutrition Research Institute, Philippines at 14 sites in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jason Paolo H. Labrador, RND, MSPH (8837-8113 ext. local 308, jasonpaolo.labrador@fnri.dost.gov.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (in kilograms) and age (in years and months) will be combined to report Weight-for-Age in Z-score (time frame: Month 0 (Baseline), Month 6 (Midline), and Month 12 (Endline)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07837336, which also lists 73 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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