Chronic Liver DiseaseNCT04022941
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
A study testing Sodium Benzoate and Powdered table sugar as palcebo in people with Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Subject will be randomize in two groups. Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.Since the dosage of Sodium Benzoate is Sta t250mg/Kg and then 250mg/Kg in next 24 hours, each patient would be given 750mg /kg stat and 750mg /kg in next 24 hours,keeping… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Sodium Benzoate and Powdered table sugar as palcebo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2017to 31 Dec 2018
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia < 400 mcgm and /dl.
Who cannot join
- Patients who have received sodium benzoate within 1 week priorto evaluation.
- Baseline serum sodium above 155 mEq/L
- Patients with Grade 3 ascites as per IAC classification.
- Patients who did not give a written informed consent.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescents With Chronic Liver Disese - A Randomised Controlled Trial.
Subject will be randomize in two groups. Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.Since the dosage of Sodium Benzoate is Sta t250mg/Kg and then 250mg/Kg in next 24 hours, each patient would be given 750mg /kg stat and 750mg /kg in next 24 hours,keeping in view that 2/3 of powder used would be powdered sugar in the intervention arm. The dose of the powder used would be doubled in case of the ammonia level more than 300 mcg/dl. The drug will be prepared in sterile water and administered per orally or via the nasogastric tube. All the enrolled patients would be treated with SMT as per the recommendations of the EASL/AASLD 2014 guidelines of management of hepatic encephalopathy.
Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
- Conditions
- Chronic Liver Disease
- Being tested
- Sodium Benzoate, Powdered table sugar as palcebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium BenzoateDrug
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.
Powdered table sugar as palceboOther
Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Benzoate | Experimental | Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days. Receives: Drug: Sodium Benzoate |
| Placebo | Placebo comparator | Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate. Receives: Other: Powdered table sugar as palcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the blood ammonia levels at 5 days of starting therapy in both groups.
Measured: Day 5
Secondary outcomes (12)
Change in the grading of Hepatic Encephalopathy in both groups.
Measured: Day 28
Change in the grading of Hepatic Encephalopathy in both groups.
Measured: Day 90
Proportion of children with worsening ascites in both groups.
Measured: Day 28
Proportion of children with worsening ascites in both groups.
Measured: Day 90
Proportion of children with hypernatremia in both groups.
Measured: Day 28
Proportion of children with hypernatremia in both groups.
Measured: Day 90
Proportion of children with metabolic acidosis in both groups.
Measured: Day 28
Proportion of children with metabolic acidosis in both groups.
Measured: Day 90
Duration of hospital stay in both groups.
Measured: Day 28
Duration of hospital stay in both groups.
Measured: Day 90
Short term survival with native liver in both groups
Measured: Day 28
Short term survival with native liver in both groups
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022941
- Sponsor's protocol ID
- ILBS-Cirrhosis-22
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescents With Chronic Liver Disese - A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04022941
- Acronym / sponsor ID
- ILBS-Cirrhosis-22
- Conditions
- Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Jul 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.
Subject will be randomize in two groups. Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.Since the dosage of Sodium Benzoate is Sta t250mg/Kg and then 250mg/Kg in next 24 hours, each patient would be given 750mg /kg stat and 750mg /kg in next 24 hours,keeping in view that 2/3 of powder used would be powdered sugar in the intervention arm. The dose of the powder used would be doubled in case of the ammonia level more than 300 mcg/dl. The drug will be prepared in sterile water and administered per orally or via the nasogastric tube. All the enrolled patients would be treated with SMT as per the recommendations of the EASL/AASLD 2014 guidelines of management of hepatic encephalopathy.
Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Benzoate | Experimental | Drug: Sodium BenzoateGroup A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days. |
| Placebo | Placebo comparator | Other: Powdered table sugar as palceboGroup B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia < 400 mcgm and /dl.
Key exclusion criteria (4 listed)
- Patients who have received sodium benzoate within 1 week priorto evaluation.
- Baseline serum sodium above 155 mEq/L
- Patients with Grade 3 ascites as per IAC classification.
- Patients who did not give a written informed consent.
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 |
|---|---|---|
| Sodium BenzoateGroup A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days. | Drug | Sodium Benzoate |
| Powdered table sugar as palceboGroup B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate. | Other | Placebo |
Primary outcome
Change in the blood ammonia levels at 5 days of starting therapy in both groups.
Time frame: Day 5
12 secondary outcomes
Change in the grading of Hepatic Encephalopathy in both groups.
Time frame: Day 28
Change in the grading of Hepatic Encephalopathy in both groups.
Time frame: Day 90
Proportion of children with worsening ascites in both groups.
Time frame: Day 28
Proportion of children with worsening ascites in both groups.
Time frame: Day 90
Proportion of children with hypernatremia in both groups.
Time frame: Day 28
Proportion of children with hypernatremia in both groups.
Time frame: Day 90
Proportion of children with metabolic acidosis in both groups.
Time frame: Day 28
Proportion of children with metabolic acidosis in both groups.
Time frame: Day 90
Duration of hospital stay in both groups.
Time frame: Day 28
Duration of hospital stay in both groups.
Time frame: Day 90
Short term survival with native liver in both groups
Time frame: Day 28
Short term survival with native liver in both groups
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Benzoate and Powdered table sugar as palcebo in people with Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the blood ammonia levels at 5 days of starting therapy in both groups. (time frame: Day 5). 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 17 Jul 2019.