1. Home
  2. Approved trials
  3. » فارسی

Comparison of the efficiency of nanomicellar formulation with standard formulation of fat-soluble vitamins in patients with cystic fibrosis

Protocol summary

Study aim
The aim of this study is to evaluate the efficiency of nanomicellar form of fat-soluble vitamins in patients with cystic fibrosis and also evaluating of the effectiveness of improving the serum level of fat-soluble vitamins, complications of fat-soluble vitamins deficiency, quality of life in cystic fibrosis patients and Anthropometric criteria (height, weight, and BMI) in the use of nanomicellar form of fat-soluble vitamins compared to the standard form
Design
Two arm parallel group randomized trial, one way blinded and phase 3 on 74 patients. Excel software or dedicated randomization sites will be used for randomization
Settings and conduct
The study site is Cystic Fibrosis Clinic in Akbar Children's Hospital. The duration of the study is 3 months. Only the data analyzer will be unaware of the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with cystic fibrosis over 8 years old who have been diagnosed based on clinical signs and sweat test, have pulmonary and gastrointestinal problems, have an oxygen saturation greater than or equal to 90%, be in clinically stable condition, and have informed consent; Exclusion criteria include patients with cystic fibrosis who have heart, liver, or kidney failure, patients with celiac disease, or who do not follow the medical treatment.
Intervention groups
The intervention group is patients with cystic fibrosis who use drops containing a combination of nanomicellar form of fat-soluble vitamins with a daily dosage of 1 cc; The control group is patients with cystic fibrosis who receive each of the fat-soluble vitamins in a standard and separate form with the appropriate dosage for cystic fibrosis patients
Main outcome variables
Measurement of serum levels of fat-soluble vitamins; Evaluation of patients' clinical symptoms, growth status, quality of life, and treatment adherence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220415054541N1
Registration date: 2022-07-23, 1401/05/01
Registration timing: prospective

Last update: 2022-07-23, 1401/05/01
Update count: 0
Registration date
2022-07-23, 1401/05/01
Registrant information
Name
Mahsa Soleimanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3763 6773
Email address
soleimanzadehm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficiency of nanomicellar formulation with standard formulation of fat-soluble vitamins in patients with cystic fibrosis
Public title
Evaluation of the efficiency of nanomicellar formulation of fat-soluble vitamins in cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cystic fibrosis who have been diagnosed based on clinical signs and sweat test Age 8 years and above Have pulmonary and gastrointestinal problems Oxygen saturation percentage based on pulse oximetry is greater than or equal to 90% at room temperature Be in clinically stable condition Have informed consent to participate in the study
Exclusion criteria:
The patient with heart, liver or kidney failure The patient with celiac disease The patient who do not follow medical treatment
Age
From 8 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple and individual way. Randomization is done using Excel software or dedicated randomization sites such as www.randomization.com, and two groups are identified as A and B or even and odd codes. According to the obtained sequence, we put the numbers in the sealed envelopes, and when the patients visit the clinic, one of the envelopes is selected, and according to the code written in it, the patient is placed in the intervention or control category
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
3rd Floor, No. 31, Khayyam 24 St., Khayyam Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187683999
Approval date
2022-05-17, 1401/02/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.116

Health conditions studied

1

Description of health condition studied
Cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis

Primary outcomes

1

Description
Serum level of fat-soluble vitamins
Timepoint
Measurement of serum level of fat-soluble vitamins once at the beginning of the study (before the intervention) and once at the end of the study (3 months after the starting of intervention)
Method of measurement
Blood test

Secondary outcomes

1

Description
Clinical symptoms of patients
Timepoint
At the end of the study (3 months after the starting of intervention)
Method of measurement
Shwachman-Kulczycki Score (an indicator for assessing the severity of the disease in cystic fibrosis patients) which includes general activity, physical examination, nutrition and radiological findings

2

Description
Growth status
Timepoint
Once at the beginning of the study (before the intervention) and once at the end of the study (3 months after the starting of intervention)
Method of measurement
Based on changes in weight, height and Body mass index

3

Description
Quality of life score
Timepoint
At the end of the study (3 months after the starting of intervention)
Method of measurement
Cystic fibrosis patients' quality of life questionnaire

4

Description
The adherence to treatment
Timepoint
At the end of the study (3 months after the starting of intervention)
Method of measurement
The number of days she/he has taken the medicine

Intervention groups

1

Description
Intervention group: Patients with cystic fibrosis who use the drop containing the composition of nanomicellar formulation of vitamins A, D, E, and K at a daily dosage of 1 cc (each cc contains 1500 units of vitamin A, 3000 units of vitamin D, 150 units of vitamin E and 1000 micrograms of vitamin K) for 3 months
Category
Treatment - Drugs

2

Description
Control group: Patients with cystic fibrosis who use the standard formulation of vitamins A, D, E and K separately with appropriate dosage for cystic fibrosis patients (10,000 units of vitamin A, 5000 units of vitamin D, 400 units of vitamin E and 500 micrograms of vitamin K daily) for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Mahsa Soleimanzadeh
Street address
Akbar Children's Hospital, Shahid Fakouri 94 St., Shahid Fakouri Blvd., Knowledge and Health Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
ak.pr@mums.ac.ir
Web page address
https://akbar.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Mashhad University of Medical Sciences, Ferdowsi University Campus, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Soleimanzadeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Floor. 3, No. 31, Alley. 24, South Khayyam Ave., Khayyam Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187683999
Phone
+98 51 3763 6773
Fax
Email
soleimanzadehm951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Soleimanzadeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Floor. 3, No. 31, Alley. 24, South Khayyam Ave., Khayyam Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187683999
Phone
+98 51 3763 6773
Fax
Email
soleimanzadehm951@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Soleimanzadeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Floor. 3, No. 31, Alley. 24, South Khayyam Ave., Khayyam Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187683999
Phone
+98 51 3763 6773
Fax
Email
soleimanzadehm951@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...