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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220415054541N1

Enrollment

Registered

2022-07-23

Start date

2022-08-23

Completion date

Unknown

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis. Cystic fibrosis

Interventions

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

Eligibility

Sex/Gender

All

Age

8 Years to No maximum

Inclusion 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

Exclusion criteria: The patient with heart, liver or kidney failure The patient with celiac disease The patient who do not follow medical treatment

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Soleimanzadeh

Mashhad University of Medical Sciences

soleimanzadehm951@mums.ac.ir+98 51 3763 6773

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026