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Completed

NCT Number: NCT07288619

Therapeutic Efficacy of Nutritional Supplementation in Cachexia Associated With Chronic Pulmonary Disease

Pulmonary cachexia, observed in individuals with chronic obstructive pulmonary disease (COPD) is a multifactorial syndrome characterized by disruptions in energy metabolism, increased protein degradation, and an impaired capacity to preserve muscle mass. These metabolic disturbances not only exacerbate the underlying respiratory condition but also significantly contribute to elevated mortality rates among affected individuals.

Current therapeutic strategies for managing cachexia primarily emphasize pharmacological treatments, nutritional interventions, and multimodal approaches. Among the nutritional interventions, various supplements have shown potential in mitigating the catabolic processes associated with cachexia. Notably, supplementation with n-3 polyunsaturated fatty acids (n-3 PUFAs) and vitamin D has emerged as a promising intervention, likely due to their involvement in key pathological mechanisms underlying the disease.

While previous studies have investigated the combined effects of these supplements through oral nutritional supplementation, this study aims to evaluate and compare the clinical effectiveness of n-3 PUFAs and vitamin D as distinct therapeutic interventions for managing pulmonary cachexia.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Body Weight Body Weight Changes Cachexia Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Thinness Weight Loss

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulab Devi Teaching Hospital, Lahore

Lahore, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide both written and verbal consent.
  • Clinically diagnosed with chronic obstructive pulmonary disease (COPD).
  • Diagnosis of pulmonary cachexia according to Cachexia Consensus Conference criteria

Exclusion criteria

  • Patients experiencing acute exacerbations of COPD.
  • Patients with co-morbid chronic diseases that can also cause cachexia, including cancer, HIV/AIDS, heart failure, chronic renal failure, liver cirrhosis, and rheumatoid arthritis
  • Pregnant women and patients with abnormal liver and/or renal function tests.
  • Patients who have taken n-3 PUFAs, Vitamin D, or any intervention for cachexia in the past four weeks.
  • Patients on oral or parenteral corticosteroids for more than four weeks.
  • Patients with a history of allergies to fish-derived products, n-3 polyunsaturated fatty acids (PUFAs), or Vitamin D.
  • Patients with a metabolic disorder that can lead to changes in body composition.

Treatment and study plan

N-3 Polyunsaturated Fatty Acids (PUFA)

Dietary Supplement

Dosage, 1000 mg per dose; Frequency, Twice daily (BID); Duration, Six weeks; Administration Route, Oral softgel capsule; Manufacturer, Donated by NOW Foods (Bloomingdale, Illinois, USA).

Vitamin D

Dietary Supplement

Dosage, 1000 IU per dose (total 2000 IU per day); Frequency, Twice daily (BID); Duration, Six weeks; Administration Route, Oral softgel capsule; Manufacturer, Donated by NOW Foods (Bloomingdale, Illinois, USA).

Primary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline and Week 6

    Change in BMI from baseline (pre-intervention), measured using a calibrated weight and height scale, and expressed in kg/m².

  2. Fat-Free Mass Index (FFMI)

    Time frame: Baseline and week 6

    Change in FFMI from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².

  3. Fat Mass Index (FMI)

    Time frame: Baseline and week 6

    Change in FFM from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².

  4. Handgrip Strength (HGS)

    Time frame: Baseline and week 6

    Change from baseline HGS measured in kilograms using a calibrated dynamometer.

  5. Mid-Arm Muscle Circumference (MAMC)

    Time frame: Baseline and week 6

    Change in MAMC from baseline (pre-intervention), calculated using the formula: MAMC = Mid-Arm Circumference (MAC) - (π × Triceps Skinfold (TSF)), expressed in centimeters (cm). The Mid-Arm Circumference (MAC) is measured using a flexible tape measure at the midpoint of the upper arm, and Triceps Skinfold (TSF) is measured using skinfold caliper.

  6. Simplified Nutritional Appetite Questionnaire (SNAQ) - Anorexia

    Time frame: Baseline and week 6

    Change in SNAQ score from baseline (pre-intervention). SNAQ is a brief, four-item screening tool used to assess anorexia with a score of 14 or below indicates poor appetite.

  7. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: Baseline and week 6

    Change in FACIT-F score from baseline (pre-intervention). FACIT-F is a 13-item scale used to assess the severity of fatigue in patients with chronic illnesses, with a scale range of 0 to 52. Higher scores indicate less fatigue (better functional status), while lower scores indicate more severe fatigue (worse functional status).

  8. Edmonton Symptom Assessment System (ESAS) - Symptom Burden

    Time frame: Baseline and week 6

    Change in ESAS score from baseline (pre-intervention). ESAS is a multi-item scale used to assess symptom burden in patients. The scale ranges from 0 to 100, with higher scores indicating greater symptom severity and lower scores indicating less severe symptoms

Secondary outcomes

  1. Medication Adherence

    Time frame: Week 6

    Percentage of patients achieving medication adherence of 80% or more, as assessed through pill count.

  2. Adverse Effects

    Time frame: Eight weeks

    Percentage of patients experiencing adverse effects, assessed throughout the study.

Sponsors and collaborators

Lead sponsor

Safeer Khan

Other

Collaborators

  • University of Lahore

Registry information

Official study title

Evaluation of the Clinical Effectiveness of Nutritional Supplements in Pulmonary Cachexia: A Quasi-Experimental Trial of n-3 PUFAs and Vitamin D

Acronym: CATCH-PulMo

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Jun 4, 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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