Clinical trial NCT06016959: Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
Official title: Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 8 months
measure: Completion rate
timeFrame: 3 months
measure: Compliance
timeFrame: Defined by increased energy & protein intake versus run-in (three-day diet-diaries).
Secondary outcomes:
measure: Nutritional status (Malnutrition)
timeFrame: 3 months
measure: Nutritional status (gastrointestinal related symptoms)
timeFrame: 3 months
measure: Anthropometrics (weight)
timeFrame: 3 months
measure: Anthropometrics (height)
timeFrame: 3 months
measure: Anthropometrics (Body Mass Index)
timeFrame: 3 months
measure: Handgrip strength
timeFrame: 3 months
measure: Quality of Life (QoL)
timeFrame: 3 months
measure: Energy and Protein intake
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References: