Evaluation of the efficiency of nanomicellar formulation of fat-soluble vitamins in cystic fibrosis
Phase 3
Recruiting
- Conditions
- Cystic fibrosis.Cystic fibrosis
- Registration Number
- IRCT20220415054541N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 74
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.;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.;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.;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.