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IRCT20220415054541N1 IRCT 2022-07-23 Mashhad University of Medical Sciences Evaluation of the efficiency of nanomicellar formulation of fat-soluble vitamins in cystic fibrosis Comparison of the efficiency of nanomicellar formulation with standard formulation of fat-soluble vitamins in patients with cystic fibrosis 2022-08-23 anticipated 74 Complete https://irct.ir/trial/64108 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 Cystic fibrosis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mahsa Soleimanzadeh
Floor. 3, No. 31, Alley. 24, South Khayyam Ave., Khayyam Blvd.
Mashhad Iran (Islamic Republic of) 9187683999 +98 51 3763 6773 soleimanzadehm951@mums.ac.ir Mashhad University of Medical Sciences scientific Mahsa Soleimanzadeh
Floor. 3, No. 31, Alley. 24, South Khayyam Ave., Khayyam Blvd.
Mashhad Iran (Islamic Republic of) 9187683999 +98 51 3763 6773 soleimanzadehm951@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 8 years no limit Both The patient with heart, liver or kidney failure The patient with celiac disease The patient who do not follow medical treatment E84 Cystic fibrosis Treatment - Drugs Treatment - Drugs 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 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 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. 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. Mashhad University of Medical Sciences Approved 2022-05-17 Ethics committee of Mashhad University of Medical Sciences 3rd Floor, No. 31, Khayyam 24 St., Khayyam Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)