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

Safeer Khan

Status: Active, not recruiting

Conditions: Cachexia; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: N-3 Polyunsaturated Fatty Acids (PUFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07288619

AAMC/IRB/EA112025

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Control

No Intervention group

N-3 Polyunsaturated Fatty Acids (PUFA)

Experimental group

Treatment:

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

Vitamin D

Experimental group

Treatment:

Dietary Supplement: Vitamin D