Cholestasis of Parenteral NutritionUDACPPNACNCT05043194
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis
A study testing Ursodeoxycholic Acid 250 Mg Oral Capsule in people with Cholestasis of Parenteral Nutrition, run by Wei Liu at 1 site in China.
Trial summary
This study aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related cholestasis in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 28 years
- Conditions the study is for
- Cholestasis of Parenteral Nutrition
- What is being tested?
- Ursodeoxycholic Acid 250 Mg Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jul 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 1 day to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- admission to the hospital within 24 hours after birth
- gestational ages:28-32 weeks
- requiring TPN during the first days of life
Who cannot join
- major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality
- surgical treatment was taken during hospitalization
- with severe symptoms of digestive system disease before TPN
- incompletion or withdrawal of treatment during hospitalization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wei Liu
Wuhan, Hubei, 430030
wei liu, doctor, 027-83663332, liuweistudy@126.com
siying liu, master, 027-83663332, liusiying5200527@qq.com
About this study
Official title: The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants
This study aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related cholestasis in preterm infants. This study examined the safety and efficacy of ursodeoxycholic acid (UDCA) in preventing Cholestasis Associated with Total Parenteral Nutrition in preterm infants.
Read the detailed description
Investigators compared oral administration of UDCA prophylaxis with no prophylaxis in a randomized, open-label, proof-of-concept trial in preterm neonates with PN therapy.
- Conditions
- Cholestasis of Parenteral Nutrition
- Being tested
- Ursodeoxycholic Acid 250 Mg Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic Acid 250 Mg Oral CapsuleDrug
prevention
| Study group | Role | What they receive |
|---|---|---|
| ursodeoxycholic acid arm | Experimental | Premature infants who meet the inclusion criteria take preventive oral ursodeoxycholic acid on the 7th day after birth. ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged . Receives: Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule |
| the control arm | Sham comparator | The control group was treated with UDCA after the occurrence of cholestasis.ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged . Receives: Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
direct bilirubin value of participants
Weekly direct bilirubin values in μmol/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis
Measured: up to 10 weeks
Secondary outcomes (1)
The γ-GT activity level of participants
Weekly γ-GT values in U/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Jan 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholestasis of Parenteral NutritionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Liu, Tongji Hospital
- Investigators
- liwen chang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043194
- Sponsor's protocol ID
- wei liu
- Acronym
- UDACPPNAC
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants
- ClinicalTrials.gov ID
- NCT05043194
- Acronym / sponsor ID
- UDACPPNAC / wei liu
- Conditions
- Cholestasis of Parenteral Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wei LiuUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 14 Sep 2021 (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 aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related cholestasis in preterm infants. This study examined the safety and efficacy of ursodeoxycholic acid (UDCA) in preventing Cholestasis Associated with Total Parenteral Nutrition in preterm infants.
Detailed description
Investigators compared oral administration of UDCA prophylaxis with no prophylaxis in a randomized, open-label, proof-of-concept trial in preterm neonates with PN therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ursodeoxycholic acid arm | Experimental | Drug: Ursodeoxycholic Acid 250 Mg Oral CapsulePremature infants who meet the inclusion criteria take preventive oral ursodeoxycholic acid on the 7th day after birth. ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged . |
| the control arm | Sham comparator | Drug: Ursodeoxycholic Acid 250 Mg Oral CapsuleThe control group was treated with UDCA after the occurrence of cholestasis.ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged . |
Who may qualify
- Ages
- 1 day to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- admission to the hospital within 24 hours after birth
- gestational ages:28-32 weeks
- requiring TPN during the first days of life
Key exclusion criteria (4 listed)
- major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality
- surgical treatment was taken during hospitalization
- with severe symptoms of digestive system disease before TPN
- incompletion or withdrawal of treatment during hospitalization
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 |
|---|---|---|
| Ursodeoxycholic Acid 250 Mg Oral Capsuleprevention | Drug | the control arm, ursodeoxycholic acid arm |
Primary outcome
direct bilirubin value of participants
Time frame: up to 10 weeks
Weekly direct bilirubin values in μmol/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis
1 secondary outcome
The γ-GT activity level of participants
Time frame: up to 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- 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.
liwen chang principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic Acid 250 Mg Oral Capsule in people with Cholestasis of Parenteral Nutrition, run by Wei Liu at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
direct bilirubin value of participants (time frame: up to 10 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 20 Sep 2021.