Chronic Obstructive Pulmonary Disease (COPD)CATCH-PulMoNCT07288619
Therapeutic Efficacy of Nutritional Supplementation in Cachexia Associated With Chronic Pulmonary Disease
A study testing N-3 Polyunsaturated Fatty Acids (PUFA) and Vitamin D in people with Chronic Obstructive Pulmonary Disease (COPD) and Cachexia, run by Safeer Khan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Cachexia
- What is being tested?
- N-3 Polyunsaturated Fatty Acids (PUFA) and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- N-3 Polyunsaturated Fatty Acids (PUFA), Vitamin D
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Vitamin DDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| N-3 Polyunsaturated Fatty Acids (PUFA) | Experimental | Not described Receives: Dietary Supplement: N-3 Polyunsaturated Fatty Acids (PUFA) |
| Vitamin D | Experimental | Not described Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 6
Handgrip Strength (HGS)
Change from baseline HGS measured in kilograms using a calibrated dynamometer.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Baseline and week 6
Secondary outcomes (2)
Medication Adherence
Percentage of patients achieving medication adherence of 80% or more, as assessed through pill count.
Measured: Week 6
Adverse Effects
Percentage of patients experiencing adverse effects, assessed throughout the study.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Oct 2025
- Primary completion15 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Safeer Khan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Sponsor-investigator, Safeer Khan, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288619
- Sponsor's protocol ID
- AAMC/IRB/EA112025
- Acronym
- CATCH-PulMo
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28891198van 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.
PubMed 30954363
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Effectiveness of Nutritional Supplements in Pulmonary Cachexia: A Quasi-Experimental Trial of n-3 PUFAs and Vitamin D
- ClinicalTrials.gov ID
- NCT07288619
- Acronym / sponsor ID
- CATCH-PulMo / AAMC/IRB/EA112025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Safeer KhanUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | N-3 Polyunsaturated Fatty Acids (PUFA) |
| Vitamin DDosage, 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). | Dietary supplement | Vitamin D |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: Baseline and Week 6
Change in BMI from baseline (pre-intervention), measured using a calibrated weight and height scale, and expressed in kg/m².
Fat-Free Mass Index (FFMI)
Time frame: Baseline and week 6
Change in FFMI from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².
Fat Mass Index (FMI)
Time frame: Baseline and week 6
Change in FFM from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².
Handgrip Strength (HGS)
Time frame: Baseline and week 6
Change from baseline HGS measured in kilograms using a calibrated dynamometer.
Mid-Arm Muscle Circumference (MAMC)
Time frame: Baseline and week 6
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.
Simplified Nutritional Appetite Questionnaire (SNAQ) - Anorexia
Time frame: Baseline and week 6
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.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Baseline and week 6
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).
Edmonton Symptom Assessment System (ESAS) - Symptom Burden
Time frame: Baseline and week 6
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
2 secondary outcomes
Medication Adherence
Time frame: Week 6
Adverse Effects
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 28891198Calder 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.
- Background: PubMed 30954363van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-3 Polyunsaturated Fatty Acids (PUFA) and Vitamin D in people with Chronic Obstructive Pulmonary Disease (COPD) and Cachexia, run by Safeer Khan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Baseline and Week 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07288619, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.