Nocturnal nutritional supplementation in advanced liver disease - a randomised trial

A randomised trial of effects on total body protein status of nocturnal versus daytime nutritional supplementation in patients with liver cirrhosis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000450617

Enrollment

110

Registered

2005-09-21

Start date

2000-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Single-centre, stratified, randomised study to compare total body protein changes in patients with liver cirrhosis taking a nutritional supplement (2 cans Ensure Plus or equivalent) either at night-time or daytime for 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with chronic liver disease referred for nutritional support who have cirrhosis of the liver. Written informed consent.

Exclusion criteria

Unable or unwilling to take the food supplement as prescribed; on waiting list for liver transplantation.

Outcome results