Status:
COMPLETED
Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Malnutrition occurs when the body receives too few nutrients, resulting in health problems such as weight loss. The consequences of malnutrition are worrying as they include lung failure, infection, a...
Eligibility Criteria
Inclusion
- BMI ≤ 20kg/m2, or if aged \>75, BMI ≤ 21 (Righini et al., 2013)
- Over the past 12 months, unintentional weight loss ≥ 5% of body weight, regardless of baseline BMI or weight loss \>2 kg if BMI is normal.
Exclusion
- Co-morbidities currently requiring a specialised diet (including enteral feeding)
- End of life care (estimated less than 6 weeks left to live)
- Expected introduction of anti-fibrotic or immunosuppressive treatment or introduction/increase corticosteroid dose during trial period
- Pregnancy
- Unable to give consent
Key Trial Info
Start Date :
June 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06016959
Start Date
June 20 2023
End Date
June 1 2024
Last Update
January 31 2025
Active Locations (1)
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1
Royal Brompton Hospital
London, United Kingdom