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

September 28, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ebner Bon G. Maceda, MD, FPPS
  • Phone Number: 63 2 8526-1725
  • Email: egmaceda@up.edu.ph

Study Locations

  • Philippines
    • Batangas
      • Batangas, Batangas, Philippines, 4200
        • Not yet recruiting
        • Batangas Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carolyn I. Boongaling, MD, FPPS, FPSPME
    • Bulacan
      • Malolos, Bulacan, Philippines, 3000
        • Recruiting
        • Bulacan Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason Paolo H. Labrador, RND, MSPH
    • Cavite
      • Trece Martires, Cavite, Philippines, 4109
        • Recruiting
        • General Emilio Aguinaldo Memorial Hospital
        • Contact:
        • Contact:
          • Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
          • Phone Number: (046) 419 1716
          • Email: laguinaldo@up.edu.ph
        • Principal Investigator:
          • Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
    • Cebu
      • Cebu, Cebu, Philippines, 6000
        • Not yet recruiting
        • Vicente Sotto Memorial Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ma. Rita Anna S. Boligao, MD, FPPS
    • Laguna
      • Calamba, Laguna, Philippines, 4027
        • Recruiting
        • Dr. Jose P. Rizal Memorial District Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason Paolo H. Labrador, RND, MSPH
    • Manila
      • Manila, Manila, Philippines, 1000
        • Recruiting
        • University of the Philippines, Philippine General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ebner Bon G. Maceda, MD, FPPS
        • Sub-Investigator:
          • Kevina Mariz M. Dajoyag, RN, MSGC
    • Misamis Oriental
      • Cagayan de Oro, Misamis Oriental, Philippines, 9000
        • Recruiting
        • Northern Mindanao Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Celenia-Jo S. Cagata, MD, DPPS
        • Sub-Investigator:
          • Hezel F. Jurial, MD, DPPS
    • National Capital Region
      • City of Taguig, National Capital Region, Philippines, 1633
        • Not yet recruiting
        • Taguig City Health Centers
        • Contact:
        • Principal Investigator:
          • Jason Paolo H. Labrador, RND, MSPH
        • Contact:
      • Paranaque City, National Capital Region, Philippines, 1711
        • Recruiting
        • Parañaque Health Centers
        • Contact:
        • Principal Investigator:
          • Jason Paolo H. Labrador, RND, MSPH
        • Contact:
      • Pateros, National Capital Region, Philippines, 1620
        • Recruiting
        • Pateros Health Centers
        • Contact:
        • Principal Investigator:
          • Jason Paolo H. Labrador, RND, MSPH
        • Contact:
      • Quezon City, National Capital Region, Philippines, 1105
        • Not yet recruiting
        • Philippine Children's Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Teresa B. Bangcaya, MD, DPPS
    • Nueva Ecija
      • Cabanatuan City, Nueva Ecija, Philippines, 3100
        • Recruiting
        • Dr. Paulino J. Garcia Memorial Research and Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leah Mae C. Besa, MD
    • Pampanga
      • San Fernando City, Pampanga, Philippines, 2000
        • Recruiting
        • Jose B. Lingad Memorial General Hospital
        • Contact:
        • Contact:
          • Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
          • Phone Number: (045) 409-6688
          • Email: viani_10@yahoo.com
        • Principal Investigator:
          • Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
    • Quezon
      • Lucena City, Quezon, Philippines, 4301
        • Recruiting
        • Quezon Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josephine Leiya Marie F. Salud-Masanga, MD, FPPS, FPSPME

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)

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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Amino Acid concentration in umol/L
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Age at Diagnosis of IEIPM Participants in years and months
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Food and Nutrition Research Institute, Philippines

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason Paolo H. Labrador, RND, MSPH, Department of Science and Technology - Food and Nutrition Research Institute
  • Principal Investigator: Ebner Bon G. Maceda, MD, FPPS, University of the Philippines Manila - Institute of Human Genetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DOH SJREB 2026-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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