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

NCT07288619 | Completed

• 1 other identifier: AAMC/IRB/EA112025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Cachexia

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Medication Adherence

  Week 6

• Adverse Effects

  Eight weeks

Study Arms (3)

Control

NO INTERVENTION

N-3 Polyunsaturated Fatty Acids (PUFA)

EXPERIMENTAL

Dietary Supplement: N-3 Polyunsaturated Fatty Acids (PUFA)

Vitamin D

EXPERIMENTAL

Dietary Supplement: Vitamin D

Interventions

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).

Vitamin D

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).

N-3 Polyunsaturated Fatty Acids (PUFA)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Safeer Khan: lead
• University of Lahore: collaborator

Study Sites (1)

Gulab Devi Teaching Hospital, Lahore

Lahore, 54000, Pakistan

Location

Related Publications (2)

• Calder PC, Laviano A, Lonnqvist F, Muscaritoli M, Ohlander M, Schols A. Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):28-40. doi: 10.1002/jcsm.12228. Epub 2017 Sep 10.

  PMID: 28891198 BACKGROUND

• 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.

  PMID: 30954363 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cachexia

Interventions

Fatty Acids, Omega-3; Vitamin D

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: October 15, 2025
• Primary Completion: March 15, 2026
• Study Completion: April 15, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)