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Post-hospitalisation Nutritional Support and Gait Speed in COPD

R

Royal Brompton & Harefield NHS Foundation Trust

Status and phase

Terminated
Phase 3

Conditions

Lung Diseases, Obstructive
Pulmonary Emphysema
Respiratory Tract Diseases
Pulmonary Disease, Chronic Obstructive
Bronchitis, Chronic

Treatments

Dietary Supplement: Oral Nutritional Supplements
Dietary Supplement: Food fortification

Study type

Interventional

Funder types

Other

Identifiers

NCT02261350
2013LF004H

Details and patient eligibility

About

To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.

Enrollment

22 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ability to consent
  • Patients at moderate or severe risk of malnutrition
  • Adults over the age of 40
  • Hospitalised with an AECOPD

Exclusion criteria

  • Receiving long term parental or enteral nutrition
  • Inability to swallow or difficulty liquids
  • Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance
  • Co-existing active cancer, progressive neurological condition or active GI disorder.
  • Receiving palliative care with expectation of death within 3 months
  • Cognitive dysfunction or unable to consent

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

22 participants in 3 patient groups

Food Fortification
Experimental group
Description:
Food Fortification
Treatment:
Dietary Supplement: Food fortification
Oral Nutritional Supplements
Experimental group
Description:
Oral Nutritional Supplements - Fortisip Compact
Treatment:
Dietary Supplement: Oral Nutritional Supplements
Usual Care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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