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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)

28 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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).

Studietype

Observationeel

Inschrijving (Geschat)

176

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Ebner Bon G. Maceda, MD, FPPS
  • Telefoonnummer: 63 2 8526-1725
  • E-mail: egmaceda@up.edu.ph

Studie Locaties

  • Filippijnen
    • Batangas
      • Batangas, Batangas, Filippijnen, 4200
        • Nog niet aan het werven
        • Batangas Medical Center
        • Contact:
          • Carolyn I. Boongaling, MD, FPPS, FPSPME
          • Telefoonnummer: (043) 740 8307
          • E-mail: krolbongga@gmail.com
        • Contact:
        • Hoofdonderzoeker:
          • Carolyn I. Boongaling, MD, FPPS, FPSPME
    • Bulacan
      • Malolos, Bulacan, Filippijnen, 3000
        • Werving
        • Bulacan Medical Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Jason Paolo H. Labrador, RND, MSPH
    • Cavite
      • Trece Martires, Cavite, Filippijnen, 4109
        • Werving
        • General Emilio Aguinaldo Memorial Hospital
        • Contact:
        • Contact:
          • Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
          • Telefoonnummer: (046) 419 1716
          • E-mail: laguinaldo@up.edu.ph
        • Hoofdonderzoeker:
          • Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
    • Cebu
      • Cebu, Cebu, Filippijnen, 6000
        • Nog niet aan het werven
        • Vicente Sotto Memorial Medical Center
        • Contact:
        • Contact:
          • Ma. Rita Anna S. Boligao, MD, FPPS
          • Telefoonnummer: (032) 253 9891
          • E-mail: mrboligao@up.edu.ph
        • Hoofdonderzoeker:
          • Ma. Rita Anna S. Boligao, MD, FPPS
    • Laguna
      • Calamba, Laguna, Filippijnen, 4027
        • Werving
        • Dr. Jose P. Rizal Memorial District Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Jason Paolo H. Labrador, RND, MSPH
    • Manila
      • Manila, Manila, Filippijnen, 1000
        • Werving
        • University of the Philippines, Philippine General Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Ebner Bon G. Maceda, MD, FPPS
        • Onderonderzoeker:
          • Kevina Mariz M. Dajoyag, RN, MSGC
    • Misamis Oriental
      • Cagayan de Oro, Misamis Oriental, Filippijnen, 9000
        • Werving
        • Northern Mindanao Medical Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Celenia-Jo S. Cagata, MD, DPPS
        • Onderonderzoeker:
          • Hezel F. Jurial, MD, DPPS
    • National Capital Region
      • City of Taguig, National Capital Region, Filippijnen, 1633
        • Nog niet aan het werven
        • Taguig City Health Centers
        • Contact:
        • Hoofdonderzoeker:
          • Jason Paolo H. Labrador, RND, MSPH
        • Contact:
      • Paranaque City, National Capital Region, Filippijnen, 1711
        • Werving
        • Parañaque Health Centers
        • Contact:
        • Hoofdonderzoeker:
          • Jason Paolo H. Labrador, RND, MSPH
        • Contact:
      • Pateros, National Capital Region, Filippijnen, 1620
      • Quezon City, National Capital Region, Filippijnen, 1105
        • Nog niet aan het werven
        • Philippine Children's Medical Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Teresa B. Bangcaya, MD, DPPS
    • Nueva Ecija
      • Cabanatuan City, Nueva Ecija, Filippijnen, 3100
        • Werving
        • Dr. Paulino J. Garcia Memorial Research and Medical Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Leah Mae C. Besa, MD
    • Pampanga
      • San Fernando City, Pampanga, Filippijnen, 2000
        • Werving
        • Jose B. Lingad Memorial General Hospital
        • Contact:
        • Contact:
          • Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
          • Telefoonnummer: (045) 409-6688
          • E-mail: viani_10@yahoo.com
        • Hoofdonderzoeker:
          • Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
    • Quezon
      • Lucena City, Quezon, Filippijnen, 4301
        • Werving
        • Quezon Medical Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Josephine Leiya Marie F. Salud-Masanga, MD, FPPS, FPSPME

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 seconde tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Weight (in kilograms) and age (in years and months) will be combined to report Weight-for-Age in Z-score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plasma Amino Acid concentration in umol/L
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Age at Diagnosis of IEIPM Participants in years and months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Food and Nutrition Research Institute, Philippines

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 maart 2026

Primaire voltooiing (Geschat)

1 maart 2028

Studie voltooiing (Geschat)

1 maart 2028

Studieregistratiedata

Eerst ingediend

9 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 september 2026

Eerst geplaatst (Werkelijk)

23 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

28 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DOH SJREB 2026-20

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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