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NCT Number: NCT07740538

Malnutrition and Sarcopenia Among 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.

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Key information

Conditions

Primary Ciliary Dyskinesia (PCD) Abnormalities, Multiple Atrophy Ciliary Motility Disorders Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Malnutrition Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sarcopenia Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for children and adolescents with PCD

  • 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.
  • Cooperative individuals,
  • Individuals who have never smoked
  • Willingness to participate in the study

Inclusion criteria

for healthy children and adolescents:

  • Voluntary participation in the study

Exclusion criteria

Exclusion criteria

for children and adolescents with PCD:

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

Treatment and study plan

Physical assessments of individuals

Other

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.

Primary outcomes

  1. Handgrip Muscle Strength in Participants

    Time frame: 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.

Secondary outcomes

  1. Malnutrition risk score in Participants

    Time frame: 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.

  2. Body Weight

    Time frame: 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.

  3. Height

    Time frame: From enrollment to the end of treatment at 1 year

    In children and adolescents with PCD, height will be measured using a stadiometer.

  4. Body Mass Index

    Time frame: 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.

  5. Waist circumference

    Time frame: 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

  6. Hip circumference

    Time frame: 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

  7. Waist-to-hip ratio

    Time frame: 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.

  8. Waist-to-Height ratio

    Time frame: 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.

  9. Upper-middle arm circumference

    Time frame: 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.

  10. Triceps skinfold thickness

    Time frame: 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.

  11. Body fat percentage

    Time frame: 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.

  12. Height by Age

    Time frame: 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.

  13. Weight by Height

    Time frame: 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.

  14. Weight by Age

    Time frame: 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.

  15. Body Mass Index by Age

    Time frame: 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.

  16. Forced Expiratory Volume at One Second

    Time frame: 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).

  17. Forced Vital Capacity

    Time frame: 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).

  18. Forced Expiratory Volume at One Secondto Forced Vital Capacity Ratio

    Time frame: 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.

  19. Peak Expiratory Flow

    Time frame: 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.

  20. Forced Expiratory Flow at 25-75% of Forced Vital Capacity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gülşah BARĞI, Assoc. Dr.

CONTACT

[email protected]

+90 232 299 07 39

Kerim Kaan K GÖKÜSTÜN, Dr. Lecturer

CONTACT

[email protected]

+90 232 299 07 39

Sponsors and collaborators

Lead sponsor

Izmir Democracy University

Other

Registry information

Official study title

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

Acronym: Malnutrition

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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