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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Soleimanzadeh, Mahsa Talebi, Saeedeh Jaafari, Mahmoud Reza Sayedi, Seyed Javad Emadzadeh, Maryam Kianifar, Hamid Reza |
| Abstract | Background Cystic fibrosis is an inherited disease, which is caused by the CFTR protein defects due to mutations in the CFTR gene. Along with CFTR dysfunction, exocrine pancreatic insufficiency plays a key role in persistent fat malabsorption in CF patients; therefore, deficiency of fat-soluble vitamins (A, D, E, and K) is still a therapeutic challenge. Even with efficient pancreatic enzyme medication and CF-specific vitamins, many patients with CF have fat-soluble vitamins deficiency. The present study aims to evaluate the efficiency of nanomicelle formulation of fat-soluble vitamins in children with CF in order to achieve the appropriate serum levels of these vitamins. Methods This prospective, single-blind control trial will be conducted at the Akbar Children’s Hospital in Mashhad, Iran. Patients with CF will be enrolled based on the eligibility criteria. The control group will receive the standard formulation of fat-soluble vitamins similar to the routine CF treatment, and for the intervention group, the nanomicelle formulation of fat-soluble vitamins will be administered for 3 months. The primary outcome of this study is the measurement of serum levels of fat-soluble vitamins. The secondary outcomes are clinical assessment by the Shwachman-Kulczycki score, anthropometrics, and quality of life. Outcomes will be assessed before and after 3 months. Discussion Due to persistent fat-soluble vitamin deficiency in CF disease, the nanomicelle formulation could be proposed as a new delivery method of fat-soluble vitamins in the treatment of cystic fibrosis. Trial registration Iranian Registry of Clinical Trials IRCT20220415054541N1. Registered on July 23, 2022. |
| Related Links | https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-023-07896-8.pdf |
| Ending Page | 10 |
| Page Count | 10 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17456215 |
| DOI | 10.1186/s13063-023-07896-8 |
| Journal | Trials |
| Issue Number | 1 |
| Volume Number | 25 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2024-01-16 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Cystic fibrosis Pancreatic insufficiency Malabsorption Fat-soluble Vitamins Nanomicelle Children Randomized controlled trial Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Pharmacology (medical) |
| Journal Impact Factor | 2/2023 |
| 5-Year Journal Impact Factor | 2.1/2023 |
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