Status:
RECRUITING
Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Nutricia Research
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall objective is to investigate the efficacy of targeted nutrient supplementation on daily physical activity level as well as generic health status in patients with COPD. Additionally the inve...
Detailed Description
Rationale: Impaired physical and mental health are common features in COPD adversely affecting disease course and quality of life. Furthermore, nutritional status is often impaired due to dietary and ...
Eligibility Criteria
Inclusion
- Inclusion Criteria COPD Patients:
- COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV);
- Medically stable.
- Exclusion Criteria COPD Patients:
- Age \<18 years;
- Allergy or intolerance to components of the study product;
- Not willing or not able to quit vitamin D or fatty acid supplement intake;
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);
- Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;
- Patients with terminal illness;
- Recent hospital admission (\<4 weeks prior to the start of the study);
- Temporary oral steroid or antibiotics use due to a COPD exacerbation in the last 4 weeks;
- Lung malignancy in the previous 5 years;
- Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;
- Recent diagnosis of cerebral conditions (\<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;
- Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.
- Inclusion Criteria Healthy Controls
- Forced expiratory volume in 1 second/Forced vital capacity \> 0.7;
- Medically stable.
- Exclusion Criteria Healthy Controls
- Age \<18 years;
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);
- Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;
- Patients with terminal illness;
- Recent hospital admission (\<4 weeks prior to the start of the study);
- Temporary antibiotics use in the last 4 weeks;
- Lung malignancy in the previous 5 years;
- Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;
- Recent diagnosis of cerebral conditions (\<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;
- Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.
- Diagnosis of any chronic lung disease.
Exclusion
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03807310
Start Date
February 19 2020
End Date
July 1 2026
Last Update
January 14 2025
Active Locations (1)
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1
Maastricht University Medical Centre+ (MUMC+)
Maastricht, Limburg, Netherlands, 6202 AZ