NutritionNCT03944330
A Study on Nutrition Support Therapy of Patients With Liver Failure
A study testing standard hospital diet in people with Nutrition, run by Tongji Hospital.
Trial summary
This study is a Clinical trial to assess the efficacy of nutrition support therapy of patients with liver failure. Patients were randomized to one of 2 groups to receive different nutrition and energy support treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nutrition
- What is being tested?
- standard hospital diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2019to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients from 18 to 65 years of age;
- Patient inclusion criteria: jaundice (serum total bilirubin ≥5 mg/dl) and coagulopathy (INR ≥ 1.5 or prothrombin activity ≥ 40 %), accompanied by ascites and/or encephalopathy within 4 weeks.
Who cannot join
- Surgery with in 4 weeks
- three degree hepatoencephalopathy
- malignant tumors
- cardiac failure or respiratory failure
- liver transplantation within observing period -
About this study
Official title: A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure
This study is a Clinical trial to assess the efficacy of nutrition support therapy of patients with liver failure. Patients were randomized to one of 2 groups to receive different nutrition and energy support treatment.
Read the detailed description
Patients with liver failure (defined by APASL) induced by any precipitating factors were randomized to two groups; a treatment group and a control group. Participants in treatment group were provided with a standard hospital diet that provided 25-30 kcal/kg/day . Patients in control group receive diet guide
- Conditions
- Nutrition
- Being tested
- standard hospital diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard hospital dietDietary supplement
patients were provided standard hospital diet that provided 25-30 kcal/kg/day
| Study group | Role | What they receive |
|---|---|---|
| a treatment group | Active comparator | All study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day Receives: Dietary Supplement: standard hospital diet |
| control group | No intervention | All study participants were not intervened with diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 day
The percentage of death of liver failure patients at 4 weeks
Measured: 4 weeks
Secondary outcomes (3)
liver transplant-free survival
survival rate on 4 weeks and 3 month
Measured: 3month
Laboratory variables on serum biochemistry markers
Laboratory variables on serum lever of glutamic-pyruvic transaminase/glutamic oxalacetic transaminase/total bilirubin/ cholinesterase will be combined to report liver function
Measured: 3month
Laboratory variables on fasting blood sugar
Laboratory variables on serum lever of fasting blood sugar
Measured: 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start10 May 2019 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944330
- Sponsor's protocol ID
- Nstlf
- Status last verified
- May 2019
- First submitted
- 14 Mar 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure
- ClinicalTrials.gov ID
- NCT03944330
- Acronym / sponsor ID
- Nstlf
- Conditions
- Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 10 May 2019 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Clinical trial to assess the efficacy of nutrition support therapy of patients with liver failure. Patients were randomized to one of 2 groups to receive different nutrition and energy support treatment.
Detailed description
Patients with liver failure (defined by APASL) induced by any precipitating factors were randomized to two groups; a treatment group and a control group. Participants in treatment group were provided with a standard hospital diet that provided 25-30 kcal/kg/day . Patients in control group receive diet guide
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a treatment group | Active comparator | Dietary Supplement: standard hospital dietAll study participants were provided with a standard hospital diet that provided B25-30 kcal/kg/day |
| control group | No intervention | –All study participants were not intervened with diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients from 18 to 65 years of age;
- Patient inclusion criteria: jaundice (serum total bilirubin ≥5 mg/dl) and coagulopathy (INR ≥ 1.5 or prothrombin activity ≥ 40 %), accompanied by ascites and/or encephalopathy within 4 weeks.
Key exclusion criteria (5 listed)
- Surgery with in 4 weeks
- three degree hepatoencephalopathy
- malignant tumors
- cardiac failure or respiratory failure
- liver transplantation within observing period -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard hospital dietpatients were provided standard hospital diet that provided 25-30 kcal/kg/day | Dietary supplement | a treatment group |
Primary outcome
Mortality at 30 day
Time frame: 4 weeks
The percentage of death of liver failure patients at 4 weeks
3 secondary outcomes
liver transplant-free survival
Time frame: 3month
Laboratory variables on serum biochemistry markers
Time frame: 3month
Laboratory variables on fasting blood sugar
Time frame: 3month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing standard hospital diet in people with Nutrition, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 30 day (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.