Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial (DT-ILD)

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Interstitial Lung Disease

Treatments: Other: Diet sheet (placebo); Other: Dietetic intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06016959

327224

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Individualised dietetic advice

Experimental group

Description:

Participants will receive 5 sessions receiving individualised nutritional counselling advice from a registered dietitian.

Treatment:

Other: Dietetic intervention

Diet sheet

Placebo Comparator group

Description:

Participants will receive a diet sheet around poor appetite.

Treatment:

Other: Diet sheet (placebo)