NCT02261350

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

May 8, 2014

Last Update Submit

October 30, 2015

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Tract DiseasesLung Diseases, ObstructiveBronchitis, ChronicPulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

  • Change in four-metre gait speed (m/s) following nutritional support

    Change from baseline to 12 weeks

Secondary Outcomes (3)

  • Change in weight (kg) following nutritional support

    Change from baseline to 12 weeks

  • Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support

    Change from baseline to 12 weeks

  • Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support

    Change from baseline to 12 weeks

Study Arms (3)

Food Fortification

EXPERIMENTAL

Food Fortification

Dietary Supplement: Food fortification

Oral Nutritional Supplements

EXPERIMENTAL

Oral Nutritional Supplements - Fortisip Compact

Dietary Supplement: Oral Nutritional Supplements

Usual Care

NO INTERVENTION

Interventions

Food fortificationDIETARY_SUPPLEMENT
Food Fortification
Oral Nutritional SupplementsDIETARY_SUPPLEMENT
Also known as: Fortisip Compact, Nutricia Clinical
Oral Nutritional Supplements

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hillingdon Hospital NHS Foundation Trust

Uxbridge, Middlesex, UB8 3NN, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Tract DiseasesLung Diseases, ObstructiveBronchitis, ChronicPulmonary Emphysema

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Lung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • William Man, PhD FRCP

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

October 10, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

GB(1)