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Malnutrition and Sarcopenia Among Primary Ciliary Dyskinesia (Malnutrition)

28 de julho de 2026 atualizado por: Kerim Kaan Göküstün, Izmir Democracy University

Associations Between the Status of Malnutrition and Sarcopenia in Children and Adolescents With Primary Ciliary Dyskinesia

The prevalence and causes of malnutrition and sarcopenia in children and adolescents with Primary ciliary dyskinesia (PCD) have not been sufficiently elucidated. The aim of this study is to investigate the prevalence of malnutrition and sarcopenia in children and adolescents with PCD.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Primary ciliary dyskinesia (PCD) is an autosomal recessive disorder characterized by abnormal ciliary motility and impaired mucociliary clearance. It develops as a result of mutations in genes responsible for ciliary movement. Structural or functional abnormalities of cilia lead to chronic upper and lower respiratory tract infections, fertility problems, and organ laterality defects. The prevalence of PCD ranges from 1 in 2,000 to 1 in 40,000, varying among different ethnic groups. The disease begins to negatively affect lung function from the preschool period onward. In children with PCD, respiratory function is generally characterized by mild to moderate airway obstruction. As the disease progresses, the severity of airway obstruction increases. Therefore, regular monitoring of pulmonary function is of great importance in the management of PCD. The prevalence and causes of malnutrition and sarcopenia in children and adolescents with PCD have not been sufficiently elucidated. The aim of this study is to investigate the prevalence of malnutrition and sarcopenia in children and adolescents with PCD.

Tipo de estudo

Observacional

Inscrição (Estimado)

15

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

The study will include children and adolescents aged 6-18 years with Primary Ciliary Dyskinesia (PCD).

Descrição

Inclusion Criteria:

Inclusion criteria for children and adolescents with PCD

  1. Unexplained neonatal respiratory distress, lateralization defect, productive cough, bronchiectasis, daily nasal congestion, and pansinusitis, as well as laboratory tests such as high-speed video microscopy, transmission electron microscopy, or genetic testing according to the European Respiratory Society diagnostic guidelines.
  2. Cooperative individuals,
  3. Individuals who have never smoked
  4. Willingness to participate in the study

Inclusion criteria for healthy children and adolescents:

1. Voluntary participation in the study

Exclusion Criteria:

Exclusion criteria for children and adolescents with PCD:

  1. Individuals with any acute, chronic, or systemic illness other than PCD
  2. Individuals who smoke or are quitting smoking
  3. Individuals who are not willing to participate in the study
  4. Individuals who are uncooperative

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Patient of Primary Ciliary Dyskinesia
The study will include children and adolescents with PCD aged 6 to 18 (n=15).
Outro: Physical assessments of individuals
Participants will be evaluated in terms of nutritional status, anthropometric measurements (waist circumference, hip circumference, waist-to-height ratio, skinfold measurements) and body composition, pulmonary functions, anaerobic capacity, muscle strength.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Handgrip Muscle Strength in Participants
Prazo: From enrollment to the end of treatment at 1 year
Bilateral grip strength in children and adolescents with PCD will be measured in kgF using a hand dynamometer.
From enrollment to the end of treatment at 1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Malnutrition risk score in Participants
Prazo: From enrollment to the end of treatment at 1 year
The Nutritional Status and Growth Risk Screening Tool will be used to assess the risk of growth failure. The total score on this scale ranges from 0 to 5; a score of 0 indicates a low risk of malnutrition, a score of 1-3 indicates a moderate risk of malnutrition, and a score of 4-5 indicates a high risk of malnutrition.
From enrollment to the end of treatment at 1 year
Body Weight
Prazo: From enrollment to the end of treatment at 1 year
Body weight in children and adolescents with PCD will be measured using a pediatric scale.
From enrollment to the end of treatment at 1 year
Height
Prazo: From enrollment to the end of treatment at 1 year
In children and adolescents with PCD, height will be measured using a stadiometer.
From enrollment to the end of treatment at 1 year
Body Mass Index
Prazo: From enrollment to the end of treatment at 1 year
For children and adolescents with PCD, the body mass index will be calculated by dividing body weight by the square of height in meters.
From enrollment to the end of treatment at 1 year
Waist circumference
Prazo: From enrollment to the end of treatment at 1 year
Waist circumference in children and adolescents with PCD will be measured using a tape measure
From enrollment to the end of treatment at 1 year
Hip circumference
Prazo: From enrollment to the end of treatment at 1 year
Hip circumference in children and adolescents with PCD will be measured using a tape measure
From enrollment to the end of treatment at 1 year
Waist-to-hip ratio
Prazo: From enrollment to the end of treatment at 1 year
In children and adolescents with PCD, the waist-to-hip ratio will be calculated by dividing the waist circumference by the hip circumference.
From enrollment to the end of treatment at 1 year
Waist-to-Height ratio
Prazo: From enrollment to the end of treatment at 1 year
In children and adolescents with PCD, the waist-to-height ratio will be calculated by dividing the waist circumference by the height.
From enrollment to the end of treatment at 1 year
Upper-middle arm circumference
Prazo: From enrollment to the end of treatment at 1 year
In children and adolescents with PCD, upper arm circumference will be measured using a non-stretchable tape measure, without tightening it or leaving any slack.
From enrollment to the end of treatment at 1 year
Triceps skinfold thickness
Prazo: From enrollment to the end of treatment at 1 year
In children and adolescents with PCD, triceps skinfold thickness will be measured using a skinfold caliper.
From enrollment to the end of treatment at 1 year
Body fat percentage
Prazo: From enrollment to the end of treatment at 1 year
Body fat percentage in children and adolescents with PCD will be measured using bioelectrical impedance analysis.
From enrollment to the end of treatment at 1 year
Height by Age
Prazo: From enrollment to the end of treatment at 1 year
The percentile values for height by age in children and adolescents with PCD will be determined using data from the CDC's website.
From enrollment to the end of treatment at 1 year
Weight by Height
Prazo: From enrollment to the end of treatment at 1 year
The percentile values for Weight by Height in children and adolescents with PCD will be determined using data from the CDC's website.
From enrollment to the end of treatment at 1 year
Weight by Age
Prazo: From enrollment to the end of treatment at 1 year
The percentile values for Weight by Age in children and adolescents with PCD will be determined using data from the CDC's website.
From enrollment to the end of treatment at 1 year
Body Mass Index by Age
Prazo: From enrollment to the end of treatment at 1 year
Body Mass Index (BMI) is an anthropometric index calculated by dividing body weight in kilograms by the square of height in meters. Body Mass Index by Age (BMI-for-Age) is the body mass index (BMI) adjusted for age and sex and interpreted using age- and sex-specific growth reference charts.The percentile values for Body Mass Index by Age in children and adolescents with PCD will be determined using data from the CDC's website.
From enrollment to the end of treatment at 1 year
Forced Expiratory Volume at One Second
Prazo: From enrollment to the end of treatment at 1 year
Forced Expiratory Volume at One Second is the volume of air that an individual can forcibly exhale during the first second of a maximal forced expiration following a full inspiration. It is typically expressed in liters or as a percentage of the predicted value (% predicted).
From enrollment to the end of treatment at 1 year
Forced Vital Capacity
Prazo: From enrollment to the end of treatment at 1 year
Forced Vital Capacity is the total volume of air that an individual can forcibly exhale after taking a maximal inspiration. It is typically expressed in liters (L) or as a percentage of the predicted value (% predicted).
From enrollment to the end of treatment at 1 year
Forced Expiratory Volume at One Secondto Forced Vital Capacity Ratio
Prazo: From enrollment to the end of treatment at 1 year
Forced Expiratory Volume at One Second to Forced Vital Capacity Ratio is the proportion of the forced vital capacity that is exhaled during the first second of a forced expiration following a maximal inspiration. It is expressed as a percentage.
From enrollment to the end of treatment at 1 year
Peak Expiratory Flow
Prazo: From enrollment to the end of treatment at 1 year
Peak Expiratory Flow is the maximum expiratory flow rate achieved during a forced expiration following a maximal inspiration. It is typically expressed in liters per minute.
From enrollment to the end of treatment at 1 year
Forced Expiratory Flow at 25-75% of Forced Vital Capacity
Prazo: From enrollment to the end of treatment at 1 year
Forced Expiratory Flow at 25-75% of Forced Vital Capacity is the average forced expiratory flow measured during the middle 50% of the forced vital capacity maneuver, specifically between 25% and 75% of the exhaled volume. It is typically expressed in liters per second.
From enrollment to the end of treatment at 1 year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Izmir Democracy University

Investigadores

  • Investigador principal: Gülşah BARĞI, Assoc. Dr., Izmir Democracy University
  • Diretor de estudo: Kerim K Göküstün, Dr. Lecturer, Izmir Democracy University
  • Investigador principal: Aybüke Sena DEMİR, MSc., Izmir Democracy University
  • Investigador principal: Ece OCAK, Dr., University of Health science

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

3 de agosto de 2026

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

1 de julho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de julho de 2026

Primeira postagem (Real)

31 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Primary Ciliary Dyskinesia

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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