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| Name | Class |
|---|---|
| University of Lahore | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| N-3 Polyunsaturated Fatty Acids (PUFA) | Experimental |
| |
| Vitamin D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulab Devi Teaching Hospital, Lahore | Lahore | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28891198 | Background | 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. | |
| 30954363 | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| 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). |
|
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 |
| Eight weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |