Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-02 @ 2:11 AM
Study NCT ID:
NCT06016959
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2023-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Organization:
Study Overview
Official Title:
Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DT-ILD
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, and pressure ulcers.
Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and burning off energy. Additionally, medications called anti-fibrotic agents are used to slow disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting and weight loss which can result in malnutrition.
Malnutrition occurs in ILD in approximately half of patients. This is important because the main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes into consideration your weight against your height, are linked with worse outcomes in ILD. Malnutrition in ILD can also reduce eligibility for lung transplant and can impact tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is limited.
Dietitians play a key role in diagnosis and treatment of malnutrition. This is because dietary counselling by a dietitian has been shown to increase quality of life and intake of energy in other chronic diseases. There are currently no studies documenting the benefits of dietetic intervention in patients with ILD.
We propose to undertake the first feasibility study in this area. A feasibility study is a first step trial which investigates whether a study can \& should be done. The main aims of this study are:
1. How easy it is to recruit ILD patients to see a dietitian
2. Whether patients will attend dietetic appointments
3. Whether food/nutrient intake is increased following dietetic intervention
4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this study will also provide initial information about whether dietetic intervention stabilises weight, BMI \& quality of life.
Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and burning off energy. Additionally, medications called anti-fibrotic agents are used to slow disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting and weight loss which can result in malnutrition.
Malnutrition occurs in ILD in approximately half of patients. This is important because the main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes into consideration your weight against your height, are linked with worse outcomes in ILD. Malnutrition in ILD can also reduce eligibility for lung transplant and can impact tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is limited.
Dietitians play a key role in diagnosis and treatment of malnutrition. This is because dietary counselling by a dietitian has been shown to increase quality of life and intake of energy in other chronic diseases. There are currently no studies documenting the benefits of dietetic intervention in patients with ILD.
We propose to undertake the first feasibility study in this area. A feasibility study is a first step trial which investigates whether a study can \& should be done. The main aims of this study are:
1. How easy it is to recruit ILD patients to see a dietitian
2. Whether patients will attend dietetic appointments
3. Whether food/nutrient intake is increased following dietetic intervention
4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this study will also provide initial information about whether dietetic intervention stabilises weight, BMI \& quality of life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: