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Purpose <p>Persistent olfactory dysfunction severely impacts quality of life. Although Vitamin A aids tissue regeneration, poor mucosal bioavailability limits clinical efficacy. This study evaluated the effectiveness of intranasal Vitamin A nanoparticles compared to conventional Vitamin A for treating persistent olfactory loss, aiming to overcome absorption barriers.</p> Methods <p>In this randomized, double-blind trial, 60 patients with post-infectious olfactory dysfunction received either Vitamin A nanoparticles or conventional Vitamin A for six months. Nanoparticles were synthesized via nanoprecipitation and verified by electron microscopy. Monthly olfactory function was measured using Sniffin’ Sticks TDI scores. Data were analyzed using a two-way mixed-model ANOVA to assess Group × Time interactions, followed by post-hoc pairwise comparisons based on Estimated Marginal (EM) Means with Bonferroni correction to compare efficacy between the two delivery methods.</p> Results <p>A significant Group × Time interaction was observed across all olfactory domains (<i>p</i> &lt; 0.001$), confirming a superior therapeutic trajectory for the nanoparticle group. By month 6, the nanoparticle group demonstrated significantly greater improvements in threshold (Δ1.30 ± 0.18), discrimination (Δ1.30 ± 0.11), and identification (Δ1.40 ± 0.20) scores compared to the conventional group (<i>p</i> &lt; 0.05). Post-hoc analysis revealed that significant between-group divergence emerged starting from month 3. The mean TDI increase was 4.00 points in the nanoparticle group compared to 2.40 points in the conventional group.</p> Conclusion <p>Intranasal Vitamin A nanoparticles significantly outperformed conventional Vitamin A as evidenced by the mixed-model ANOVA results; however, total improvements fell short of the Minimal Clinically Important Difference (MCID). Although nanoparticle delivery enhances biological activity and absorption, the clinical impact remains modest within a 6-month window. Future research should investigate whether optimized dosing or combination therapies can achieve clinically meaningful results.</p> Clinical trial registration <p>DFM-IRB 00012367-25-07-011.</p>

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Effect of intranasal vitamin A nanoparticles on persistent olfactory dysfunction: a randomized clinical trial

  • 期刊论文

  • 发表日期：

    2026年4月29日

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  • Majed A. Algarni,
  • Fahad T. Alsulami,
  • Abdulaziz Ibrahim Alzarea,
  • Wadia S. Alruqayb,
  • Adnan Alharbi,
  • Faisal Alsenani,
  • Abdullah H. Altemani,
  • Ahmed H. Abdelazim,
  • Mohamed H. Abdelazim

摘要

Purpose

Persistent olfactory dysfunction severely impacts quality of life. Although Vitamin A aids tissue regeneration, poor mucosal bioavailability limits clinical efficacy. This study evaluated the effectiveness of intranasal Vitamin A nanoparticles compared to conventional Vitamin A for treating persistent olfactory loss, aiming to overcome absorption barriers.

Methods

In this randomized, double-blind trial, 60 patients with post-infectious olfactory dysfunction received either Vitamin A nanoparticles or conventional Vitamin A for six months. Nanoparticles were synthesized via nanoprecipitation and verified by electron microscopy. Monthly olfactory function was measured using Sniffin’ Sticks TDI scores. Data were analyzed using a two-way mixed-model ANOVA to assess Group × Time interactions, followed by post-hoc pairwise comparisons based on Estimated Marginal (EM) Means with Bonferroni correction to compare efficacy between the two delivery methods.

Results

A significant Group × Time interaction was observed across all olfactory domains (p < 0.001$), confirming a superior therapeutic trajectory for the nanoparticle group. By month 6, the nanoparticle group demonstrated significantly greater improvements in threshold (Δ1.30 ± 0.18), discrimination (Δ1.30 ± 0.11), and identification (Δ1.40 ± 0.20) scores compared to the conventional group (p < 0.05). Post-hoc analysis revealed that significant between-group divergence emerged starting from month 3. The mean TDI increase was 4.00 points in the nanoparticle group compared to 2.40 points in the conventional group.

Conclusion

Intranasal Vitamin A nanoparticles significantly outperformed conventional Vitamin A as evidenced by the mixed-model ANOVA results; however, total improvements fell short of the Minimal Clinically Important Difference (MCID). Although nanoparticle delivery enhances biological activity and absorption, the clinical impact remains modest within a 6-month window. Future research should investigate whether optimized dosing or combination therapies can achieve clinically meaningful results.

Clinical trial registration

DFM-IRB 00012367-25-07-011.