Tiny vesicles boost delivery of fat-soluble vitamins to CF patients: Trial
Nanomicelles improve absorption into bloodstream, clinical outcomes
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Packaging fat-soluble vitamins in orally available nanomicelles, or tiny vesicles that enhance drug delivery, improves absorption into the bloodstream and clinical outcomes in people with cystic fibrosis (CF) compared with standard oral supplementation, according to a clinical trial.
Fat-soluble vitamins include vitamins A, D, and E.
“This delivery system has the potential to provide a more effective alternative to conventional supplementation in the treatment of cystic fibrosis,” researchers wrote.
The study, “Evaluation of the Efficacy of a Nanomicellar Formulation of Fat-Soluble Vitamins in Patients with Cystic Fibrosis: a Randomized Controlled Trial,” was published in BioNanoScience.
Many CF patients have difficulty absorbing dietary fats
Many people with CF have pancreatic insufficiency and difficulty absorbing dietary fats into the bloodstream, which makes them prone to deficiencies of fat-soluble vitamins, including A, D, E, and K. Although CF patients are advised to take fat-soluble vitamin supplements, vitamin deficiencies can persist, particularly in children.
Nanomicelles are tiny vesicles made from amphiphilic molecules, with both water-loving (hydrophilic) and fat-loving (lipophilic) parts. They can encapsulate fat-like substances, increasing their solubility and absorption in the gastrointestinal tract, and have been used for targeted drug delivery.
Researchers in Iran conducted a clinical trial to test whether fat-soluble vitamins packaged in nanomicelles could improve vitamin absorption into the bloodstream and clinical outcomes in people with CF.
The 84 CF patients enrolled in the study were randomly assigned to receive either nanomicelle vitamins or standard vitamins, administered orally, once daily for three months. The mean age was similar between the two groups (13.9 vs. 13.1 years).
Doses for the nanomicelle group differed from those for the standard group: vitamin A (1,500 IU vs. 10,000 IU), vitamin D3 (3,000 IU vs. 5,000 IU), vitamin E (150 IU vs. 400 IU), and vitamin K (1,000 micrograms vs. 500 mcg).
After three months, the nanomicelle vitamin group showed significantly higher increases in blood vitamin D (5.73 nanograms/mL vs. 1.45 ng/mL), vitamin E (4.81 mcg/mL vs. 1.13 mcg/mL), and vitamin A (0.07 mcg/mL IU vs. 0.05 mcg/mL) than the standard vitamin group. Patients who received nanomicelles also showed significantly faster blood clotting times, an indicator of higher vitamin K levels.
Significantly fewer CF patients showed persistent deficiencies in vitamins A, E, and D after three months of nanomicelle vitamins, whereas the standard group showed no change.
Patients who received nanomicelle vitamins gained more weight
In other tests, blood cholesterol levels were significantly lower in the nanomicelle vitamin group than in the standard group. In contrast, fatty triglycerides and low-density lipoprotein, often called “bad” cholesterol, showed the opposite pattern, with significantly greater increases in response to nanomicelle vitamins.
In body measurements, individuals who received nanomicelle vitamins gained more weight and increased in height. No differences were observed in body mass index, a measure of body fat based on weight and height.
The nanomicellar vitamin group also showed a significantly lower reduction in disease severity, as indicated by Shwachman-Kulczycki scores, and improved self-reported quality of life, as measured by the Cystic Fibrosis Questionnaire-Revised score.
The study demonstrated that the nanomicellar formulation of fat-soluble vitamins is superior to other supplementation methods regarding absorption and clinical outcomes in CF patients.
Lastly, more patients adhered to the nanomicellar vitamin regimen after three months than in the standard vitamin group (87% vs. 71%), which may be attributable to the nanomicellar formulation’s improved taste, the team noted. No side effects were reported.
“The study demonstrated that the nanomicellar formulation of fat-soluble vitamins is superior to other supplementation methods regarding absorption and clinical outcomes in CF patients,” the researchers concluded.
As a limitation of the study, they noted that the follow-up was short, “which prevented us from documenting the long-term effects of nanomicellar vitamin supplementation and its side effects.”
