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Background <p>Fat-soluble vitamin deficiency remains a persistent concern in cystic fibrosis (CF) due to pancreatic insufficiency and impaired lipid absorption. Standard oral supplements frequently prove ineffective in achieving optimal serum vitamin levels, particularly in pediatric patients. Nanomicellar formulations have been demonstrated to enhance the bioavailability of hydrophobic compounds through improved solubility and absorption.</p> Methods <p>This randomized, placebo-controlled trial evaluated a three-month supplementation of fat-soluble vitamins using a novel nanomicellar formulation compared to conventional supplements in pediatric CF patients. A total of 84 enrolled patients were randomly assigned to one of two study arms: the intervention group received nanomicelle vitamins, while the control group received standard vitamins. The primary outcome was the change in serum levels of vitamins A, D, E, and coagulation markers (PT, INR, PTT). Secondary outcomes included anthropometric indices (weight, height, BMI), disease severity (Shwachman-Kulczycki score), quality of life (CFQ-R), and treatment adherence.</p> Result <p>The nanomicellar group demonstrated significantly higher increases in serum vitamin D (Δ + 5.73 ± 17.7 ng/mL vs. +1.45 ± 4.8 ng/mL, <i>p</i> = 0.02), vitamin E (Δ + 4.81 ± 2.61&#xa0;µg/mL vs. +1.13 ± 0.20&#xa0;µg/mL, <i>p</i> &lt; 0.001), and vitamin A (Δ + 0.07 ± 0.02&#xa0;µg/mL vs. +0.05 ± 0.008&#xa0;µg/mL, <i>p</i> = 0.02). PT and INR also improved significantly (<i>p</i> &lt; 0.01). The lipid ratio, commonly used to assess vitamin E status, increased significantly in the nanomicellar group (<i>p</i> &lt; 0.001). The nanomicellar group demonstrated enhancements in height and CFQ-R scores, accompanied by a substantial reduction in Shwachman-Kulczycki disease severity score (<i>p</i> &lt; 0.001). However, BMI exhibited no significant alterations. The treatment adherence rate was higher in the nanomicellar group (87.1% vs. 70.8%, <i>p</i> &lt; 0.001). No adverse effects were observed.</p> Conclusion <p>The administration of fat-soluble vitamins via nanomicellar technology has shown significant enhancement in the absorption and clinical outcomes of CF patients. This approach has been found to promote greater adherence among patients and does not raise any safety concerns. This delivery system has the potential to provide a more effective alternative to conventional supplementation in the treatment of cystic fibrosis. A small proportion of patients in the nanomicellar group developed elevated serum levels of vitamin A and E, although these remained below toxic thresholds. Therefore, dose adjustment may be warranted in future formulations.</p>

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Evaluation of the Efficacy of a Nanomicellar Formulation of Fat-Soluble Vitamins in Patients with Cystic Fibrosis: a Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2025年12月19日

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  • Mahsa Soleimanzadeh,
  • Hamid Reza Kianifar,
  • Mahmoud Reza Jaafari,
  • Saber Hakiminasab,
  • Maryam Emadzadeh,
  • Ali Jafarzadeh Esfahani,
  • Saeedeh Talebi

摘要

Background

Fat-soluble vitamin deficiency remains a persistent concern in cystic fibrosis (CF) due to pancreatic insufficiency and impaired lipid absorption. Standard oral supplements frequently prove ineffective in achieving optimal serum vitamin levels, particularly in pediatric patients. Nanomicellar formulations have been demonstrated to enhance the bioavailability of hydrophobic compounds through improved solubility and absorption.

Methods

This randomized, placebo-controlled trial evaluated a three-month supplementation of fat-soluble vitamins using a novel nanomicellar formulation compared to conventional supplements in pediatric CF patients. A total of 84 enrolled patients were randomly assigned to one of two study arms: the intervention group received nanomicelle vitamins, while the control group received standard vitamins. The primary outcome was the change in serum levels of vitamins A, D, E, and coagulation markers (PT, INR, PTT). Secondary outcomes included anthropometric indices (weight, height, BMI), disease severity (Shwachman-Kulczycki score), quality of life (CFQ-R), and treatment adherence.

Result

The nanomicellar group demonstrated significantly higher increases in serum vitamin D (Δ + 5.73 ± 17.7 ng/mL vs. +1.45 ± 4.8 ng/mL, p = 0.02), vitamin E (Δ + 4.81 ± 2.61 µg/mL vs. +1.13 ± 0.20 µg/mL, p < 0.001), and vitamin A (Δ + 0.07 ± 0.02 µg/mL vs. +0.05 ± 0.008 µg/mL, p = 0.02). PT and INR also improved significantly (p < 0.01). The lipid ratio, commonly used to assess vitamin E status, increased significantly in the nanomicellar group (p < 0.001). The nanomicellar group demonstrated enhancements in height and CFQ-R scores, accompanied by a substantial reduction in Shwachman-Kulczycki disease severity score (p < 0.001). However, BMI exhibited no significant alterations. The treatment adherence rate was higher in the nanomicellar group (87.1% vs. 70.8%, p < 0.001). No adverse effects were observed.

Conclusion

The administration of fat-soluble vitamins via nanomicellar technology has shown significant enhancement in the absorption and clinical outcomes of CF patients. This approach has been found to promote greater adherence among patients and does not raise any safety concerns. This delivery system has the potential to provide a more effective alternative to conventional supplementation in the treatment of cystic fibrosis. A small proportion of patients in the nanomicellar group developed elevated serum levels of vitamin A and E, although these remained below toxic thresholds. Therefore, dose adjustment may be warranted in future formulations.