このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年9月28日 更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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).

研究の種類

観察的

入学 (推定)

176

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Ebner Bon G. Maceda, MD, FPPS
  • 電話番号：63 2 8526-1725
  • メール：egmaceda@up.edu.ph

研究場所

  • フィリピン
    • Batangas
      • Batangas、Batangas、フィリピン、4200
        • まだ募集していません
        • Batangas Medical Center
        • コンタクト：
          • Carolyn I. Boongaling, MD, FPPS, FPSPME
          • 電話番号：(043) 740 8307
          • メール：krolbongga@gmail.com
        • コンタクト：
        • 主任研究者：
          • Carolyn I. Boongaling, MD, FPPS, FPSPME
    • Bulacan
      • Malolos、Bulacan、フィリピン、3000
        • 募集
        • Bulacan Medical Center
        • コンタクト：
        • コンタクト：
          • Ebner Bon G. Maceda, MD, FPPS
          • 電話番号：63 2 8526-1725
          • メール：egmaceda@up.edu.ph
        • 主任研究者：
          • Jason Paolo H. Labrador, RND, MSPH
    • Cavite
      • Trece Martires、Cavite、フィリピン、4109
        • 募集
        • General Emilio Aguinaldo Memorial Hospital
        • コンタクト：
        • コンタクト：
          • Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
          • 電話番号：(046) 419 1716
          • メール：laguinaldo@up.edu.ph
        • 主任研究者：
          • Laura Maria Soledad A. Aguinaldo, MD, FPPS, FPSCOT, MSc
    • Cebu
      • Cebu、Cebu、フィリピン、6000
        • まだ募集していません
        • Vicente Sotto Memorial Medical Center
        • コンタクト：
        • コンタクト：
          • Ma. Rita Anna S. Boligao, MD, FPPS
          • 電話番号：(032) 253 9891
          • メール：mrboligao@up.edu.ph
        • 主任研究者：
          • Ma. Rita Anna S. Boligao, MD, FPPS
    • Laguna
      • Calamba、Laguna、フィリピン、4027
        • 募集
        • Dr. Jose P. Rizal Memorial District Hospital
        • コンタクト：
        • コンタクト：
          • Ebner Bon G. Maceda, MD, FPPS
          • 電話番号：63 2 8526-1725
          • メール：egmaceda@up.edu.ph
        • 主任研究者：
          • Jason Paolo H. Labrador, RND, MSPH
    • Manila
      • Manila、Manila、フィリピン、1000
        • 募集
        • University of the Philippines, Philippine General Hospital
        • コンタクト：
          • Ebner Bon G. Maceda, MD, FPPS
          • 電話番号：63 2 8526-1725
          • メール：egmaceda@up.edu.ph
        • コンタクト：
          • Kevina Mariz M. Dajoyag, RN, MSGC
          • 電話番号：63 2 8526-1725
          • メール：kmdajoyag@up.edu.ph
        • 主任研究者：
          • Ebner Bon G. Maceda, MD, FPPS
        • 副調査官：
          • Kevina Mariz M. Dajoyag, RN, MSGC
    • Misamis Oriental
      • Cagayan de Oro、Misamis Oriental、フィリピン、9000
        • 募集
        • Northern Mindanao Medical Center
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Celenia-Jo S. Cagata, MD, DPPS
        • 副調査官：
          • Hezel F. Jurial, MD, DPPS
    • National Capital Region
      • City of Taguig、National Capital Region、フィリピン、1633
        • まだ募集していません
        • Taguig City Health Centers
        • コンタクト：
        • 主任研究者：
          • Jason Paolo H. Labrador, RND, MSPH
        • コンタクト：
      • Paranaque City、National Capital Region、フィリピン、1711
        • 募集
        • Parañaque Health Centers
        • コンタクト：
        • 主任研究者：
          • Jason Paolo H. Labrador, RND, MSPH
        • コンタクト：
      • Pateros、National Capital Region、フィリピン、1620
        • 募集
        • Pateros Health Centers
        • コンタクト：
        • 主任研究者：
          • Jason Paolo H. Labrador, RND, MSPH
        • コンタクト：
      • Quezon City、National Capital Region、フィリピン、1105
        • まだ募集していません
        • Philippine Children's Medical Center
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Teresa B. Bangcaya, MD, DPPS
    • Nueva Ecija
      • Cabanatuan City、Nueva Ecija、フィリピン、3100
        • 募集
        • Dr. Paulino J. Garcia Memorial Research and Medical Center
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Leah Mae C. Besa, MD
    • Pampanga
      • San Fernando City、Pampanga、フィリピン、2000
        • 募集
        • Jose B. Lingad Memorial General Hospital
        • コンタクト：
        • コンタクト：
          • Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
          • 電話番号：(045) 409-6688
          • メール：viani_10@yahoo.com
        • 主任研究者：
          • Vianney Marie C. Mandapat, MD, MHM, FPPS, DPAPP
    • Quezon
      • Lucena City、Quezon、フィリピン、4301
        • 募集
        • Quezon Medical Center
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Josephine Leiya Marie F. Salud-Masanga, MD, FPPS, FPSPME

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1秒～18年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Weight (in kilograms) and age (in years and months) will be combined to report Weight-for-Age in Z-score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Plasma Amino Acid concentration in umol/L
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

その他の成果指標

結果測定
メジャーの説明
時間枠
Mean Age at Diagnosis of IEIPM Participants in years and months
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Food and Nutrition Research Institute, Philippines

協力者

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

捜査官

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月10日

一次修了 (推定)

2028年3月1日

研究の完了 (推定)

2028年3月1日

試験登録日

最初に提出

2026年9月9日

QC基準を満たした最初の提出物

2026年9月17日

最初の投稿 (実際)

2026年9月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • DOH SJREB 2026-20

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する