Therapeutic Efficacy of Nutritional Supplementation in Cachexia Associated With Chronic Pulmonary Disease (CATCH-PulMo)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cachexia; Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Dietary supplement: N-3 Polyunsaturated Fatty Acids (PUFA); Dietary supplement: Vitamin D

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Lahore, Pakistan, 54000
    • Gulab Devi Teaching Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients experiencing acute exacerbations of COPD.
2. 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
3. Pregnant women and patients with abnormal liver and/or renal function tests.
4. Patients who have taken n-3 PUFAs, Vitamin D, or any intervention for cachexia in the past four weeks.
5. Patients on oral or parenteral corticosteroids for more than four weeks.
6. Patients with a history of allergies to fish-derived products, n-3 polyunsaturated fatty acids (PUFAs), or Vitamin D.
7. Patients with a metabolic disorder that can lead to changes in body composition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Vitamin D	Dietary supplement: Vitamin D; 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).
Experimental: N-3 Polyunsaturated Fatty Acids (PUFA)	Dietary supplement: N-3 Polyunsaturated Fatty Acids (PUFA); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI)	Change in BMI from baseline (pre-intervention), measured using a calibrated weight and height scale, and expressed in kg/m².	Baseline and Week 6
Fat-Free Mass Index (FFMI)	Change in FFMI from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².	Baseline and week 6
Fat Mass Index (FMI)	Change in FFM from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².	Baseline and week 6
Handgrip Strength (HGS)	Change from baseline HGS measured in kilograms using a calibrated dynamometer.	Baseline and week 6
Mid-Arm Muscle Circumference (MAMC)	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.	Baseline and week 6
Simplified Nutritional Appetite Questionnaire (SNAQ) - Anorexia	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.	Baseline and week 6
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	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).	Baseline and week 6
Edmonton Symptom Assessment System (ESAS) - Symptom Burden	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	Baseline and week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	Percentage of patients achieving medication adherence of 80% or more, as assessed through pill count.	Week 6
Adverse Effects	Percentage of patients experiencing adverse effects, assessed throughout the study.	Eight weeks

Collaborators and Investigators

• Sponsor: Safeer Khan
• Collaborators: University of Lahore

Publications and helpful links

General Publications

• Kolodny GM. Patterns of protein synthesis in the HeLa cancer cell. Am J Roentgenol Radium Ther Nucl Med. 1969 Apr;105(4):746-55. doi: 10.2214/ajr.105.4.746. No abstract available.
• van Beers M, Rutten-van Molken MPMH, van de Bool C, Boland M, Kremers SPJ, Franssen FME, van Helvoort A, Gosker HR, Wouters EF, Schols AMWJ. Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial. Clin Nutr. 2020 Feb;39(2):405-413. doi: 10.1016/j.clnu.2019.03.001. Epub 2019 Mar 18.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 17, 2025

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Body Weight; Respiratory Tract Diseases; Body Weight Changes; Lung Diseases; Lung Diseases, Obstructive; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Cachexia; Fatty Acids; Lipids; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Fatty Acids, Unsaturated; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fish Oils; Secosteroids; Vitamin D; Fatty Acids, Omega-3
• Other Study ID Numbers: AAMC/IRB/EA112025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No