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

NCT ID: NCT07288619

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-04-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

N-3 Polyunsaturated Fatty Acids (PUFA)

Group Type: EXPERIMENTAL

N-3 Polyunsaturated Fatty Acids (PUFA)

Intervention Type: 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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: collaborator

Safeer Khan

OTHER

Sponsor Role: lead

Responsible Party

Safeer Khan

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gulab Devi Teaching Hospital, Lahore

Lahore, , Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 5803606 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30954363 (View on PubMed)

Other Identifiers

AAMC/IRB/EA112025

Identifier Type: -

Identifier Source: org_study_id