Design, production and comparison of serum level of Ursodeoxycholic acid nano emulsion with its capsule form in infants under 5 years of age with Cholestasis.
Design
This study will be performed on 100 infants, infants and children under 5 years of age with non-obstructive cholestasis admitted to Mofid and Mahdieh Children's Hospital in Tehran as a block randomized clinical trial divided into two equal groups. Patients after obtaining a history and clinical examination by a gastroenterologist or consultations performed in the neonatal ward of Mofid Children's Hospital and Mahdieh Hospital in Tehran and after confirmation of cholestasis and rejection of obstructive causes of cholestasis in a randomized clinical trial, (6 Blocks) are divided into two equal groups. Patients are entered into the study by a checklist.
Settings and conduct
Mofid and Mahdieh Children's Hospital in Tehran.
Participants/Inclusion and exclusion criteria
This study will be performed on 100 infants, and children under 5 years of age with non-obstructive cholestasis admitted to Mofid and Mahdieh Children's Hospital in Tehran as a Blocked randomized clinical trial divided into two equal groups. Patients older than 5 years and patients with obstructive cholestasis before surgery are excluded from study.
Intervention groups
In group A, the drug will be in the form of Ursodeoxycholic acid nano emulsion in the form of drops with a dose of 15 mg/kg/d in three divided doses and in group B, the drug will be in the form of Ursodeoxycholic acid granules without capsules shell at the same dose of 15 mg/kg/ day.
Main outcome variables
Serum concentration of Ursodeoxycholic acid
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210306050598N1
Registration date:2021-05-14, 1400/02/24
Registration timing:prospective
Last update:2021-05-14, 1400/02/24
Update count:0
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Peyman Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4444 2690
Email address
peyman.ghasemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2022-02-24, 1400/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, production, and comparison of serum level of Ursodeoxycholic acid Nanoemulsion with its capsule form in infants under 5 years with cholestasis
Public title
Design, production, and comparison of serum level of Ursodeoxycholic acid Nanoemulsion with its capsule form in infants under 5 years with cholestasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants under 5 years with cholestasis
Exclusion criteria:
Infants with noncompliant parents about blood sampling.
Patients who are older than 5 year
Infants with presurgery cholestasis.
Age
To 5 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
3
whole blood sampling
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomized clinical trial. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group treatments, which keeps the numbers of subjects in each group similar at all times.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers are kept blind to the prescribed drug form (capsule or nanoemulsion). For blinding, the researcher in charge of sampling from each group, as well as the researcher in charge of drug analysis of samples, are unaware of how patients are placed in each of the groups, and the samples are coded after taking. Also, to blind the participants, capsule and nanoemulsion samples are given to them as a solution with a similar appearance.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences, faculty of Medicine
The blood samples taken from the study group were collected in heparinized tubes and after plasma separation, the plasma was frozen at a temperature of minus 20 ° C and the samples were stored. Samples will analyze by GC-Mass after one day. Calculation of pharmacokinetic factors, Cmax, AUC, Tmax is performed using GC-Mass analysis.
Secondary outcomes
1
Description
serum concentration of Ursodeoxycholic acid
Timepoint
0-1-3-5-12-24 h after drug administration
Method of measurement
The blood samples taken from the study group were collected in heparinized tubes and after plasma separation, the plasma was frozen at a temperature of minus 20 ° C and the samples were stored. Samples are analyzed by GC-Mass after one day.
Intervention groups
1
Description
Intervention group: Infants with cholestasis. These children will receive Ursodeoxycholic acid nano emulsion that produced in Shahid Beheshti School of Pharmacy at a dose of 15 mg/kg/day, in three divided doses.
Category
Treatment - Drugs
2
Description
Control group: These children will receive the contents of Ursodeoxycholic acid capsules produced in Koshan Pharmed Pharmaceutical Co. at a dose of 15 mg/kg/day, in three divided doses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's hospital
Full name of responsible person
Dr. Naghi Dara
Street address
Shariati Ave
City
Tehran
Province
Tehran
Postal code
15468155514
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
Intl_office@sbmu.ac.ir
Web page address
http://www.mch.sbmu.ac.ir/
2
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Dr. Faeze Shojaei
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq