Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial

Nowak, Jan Krzysztof; Sobkowiak, Paulina; Drzymała-Czyż, Sławomira; Krzyżanowska-Jankowska, Patrycja; Sapiejka, Ewa; Skorupa, Wojciech; Pogorzelski, Andrzej; Nowicka, Agata; Wojsyk‐Banaszak, Irena; Kurek, Szymon; Zielińska-Psuja, Barbara; Lisowska, Aleksandra; Walkowiak, Jarosław

doi:10.3390/nu13124554

Cited by 18 publications

(9 citation statements)

References 28 publications

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“…To maximize patient safety, the presence of side-effects thought to be related to taking the supplement resulted in exclusion from the study. Of note, in a previous trial, a liposomal formulation of vitamins A, D, E, and K was tested in 28 patients over three months, and no side effects have been reported [12].…”

Section: Methodsmentioning

confidence: 99%

Fat-Soluble Vitamins in Standard vs. Liposomal Form Enriched with Vitamin K2 in Cystic Fibrosis: A Randomized Multi-Center Trial

Nowak

Krzyżanowska-Jankowska

Drzymała-Czyż

et al. 2022

JCM

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Background: We aimed to assess a liposomal fat-soluble vitamin formulation containing vitamin K2 with standard treatment in cystic fibrosis (CF). Methods: A multi-center randomized controlled trial was carried out in 100 pancreatic-insufficient patients with CF. The liposomal formulation contained vitamin A as retinyl palmitate (2667 IU daily) and beta-carotene (1333 IU), D3 (4000 IU), E (150 IU), K1 (2 mg), and K2 as menaquinone-7 (400 µg). It was compared with the standard vitamin preparations in the closest possible doses (2500 IU, 1428 IU, 4000 IU, 150 IU, 2.14 mg, respectively; no vitamin K2) over 3 months. Results: Forty-two patients finished the trial in the liposomal and 49 in the control group (overall 91 pts: 22.6 ± 7.6 years, 62.6% female, BMI 19.9 ± 2.8 kg/m2, FEV1% 70% ± 30%). The main outcome was the change of vitamin status in the serum during the study (liposomal vs. standard): all-trans-retinol (+1.48 ± 95.9 vs. −43.1 ± 121.4 ng/mL, p = 0.054), 25-hydroxyvitamin D3 (+9.7 ± 13.4 vs. +2.0 ± 9.8 ng/mL, p = 0.004), α-tocopherol (+1.5 ± 2.5 vs. −0.2 ± 1.6 µg/mL, p < 0.001), %undercarboxylated osteocalcin (−17.2 ± 24.8% vs. −8.3 ± 18.5%, p = 0.061). The secondary outcome was the vitamin status at the trial end: all-trans-retinol (370.0 ± 116.5 vs. 323.1 ± 100.6 ng/mL, p = 0.045), 25-hydroxyvitamin D3 (43.2 ± 16.6 vs. 32.7 ± 11.5 ng/mL, p < 0.001), α-tocopherol (9.0 ± 3.1 vs. 7.7 ± 3.0 µg/mL, p = 0.037), %undercarboxylated osteocalcin (13.0 ± 11.2% vs. 22.7 ± 22.0%, p = 0.008). Conclusion: The liposomal fat-soluble vitamin supplement containing vitamin K2 was superior to the standard form in delivering vitamin D3 and E in pancreatic-insufficient patients with CF. The supplement was also more effective in strengthening vitamin K-dependent carboxylation, and could improve vitamin A status.

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Section: Methodsmentioning

confidence: 99%

Fat-Soluble Vitamins in Standard vs. Liposomal Form Enriched with Vitamin K2 in Cystic Fibrosis: A Randomized Multi-Center Trial

Nowak

Krzyżanowska-Jankowska

Drzymała-Czyż

et al. 2022

JCM

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“…Furthermore, patients with pancreatic insufficiency are at risk of a fat-soluble vitamin deficiency, despite enzyme replacement [ 89 ]. Liposomes can enhance the bioavailability of vitamin A, and cyclodextrins may strengthen the supplementation of vitamins D3 and E relative to the medium-chain triglycerides (MCT) in pancreatic-insufficient CF [ 90 ].…”

Section: Fat-soluble Vitaminsmentioning

confidence: 99%

Nutritional Care in Children with Cystic Fibrosis

et al. 2023

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Patients with cystic fibrosis (CF) are prone to malnutrition and growth failure, mostly due to malabsorption caused by the derangement in the chloride transport across epithelial surfaces. Thus, optimal nutritional care and support should be an integral part of the management of the disease, with the aim of ameliorating clinical outcomes and life expectancy. In this report, we analyzed the nutrition support across the different ages, in patients with CF, with a focus on the relationships with growth, nutritional status, disease outcomes and the use of the CF transmembrane conductance regulator (CFTR) modulators. The nutrition support goal in CF care should begin as early as possible after diagnosis and include the achievement of an optimal nutritional status to support the growth stages and puberty development in children, that will further support the maintenance of an optimal nutritional status in adult life. The cornerstone of nutrition in patients with CF is a high calorie, high-fat diet, in conjunction with a better control of malabsorption due to pancreatic enzyme replacement therapy, and attention to the adequate supplementation of fat-soluble vitamins. When the oral caloric intake is not enough for reaching the anthropometric nutritional goals, supplemental enteral feeding should be initiated to improve growth and the nutritional status. In the last decade, the therapeutic possibilities towards CF have grown in a consistent way. The positive effects of CFTR modulators on nutritional status mainly consist in the improvement in weight gain and BMI, both in children and adults, and in an amelioration in terms of the pulmonary function and reduction of exacerbations. Several challenges need to be overcome with the development of new drugs, to transform CF from a fatal disease to a treatable chronic disease with specialized multidisciplinary care.

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“…formulated fat‐soluble vitamins in the form of liposomes and cyclodextrins and compared them to medium‐chain triglycerides (MCT) targeted for CF patients. Vitamin A formed into liposomes augmented the bioavailability of serum all‐trans‐retinol, and cyclodextrins enhanced the serum concentration of vitamin D3 and vitamin E relative to MCT (Nowak et al., 2021 ). When given orally, vitamins present low bioavailability, irregular absorption profiles, and high patient variation.…”

Section: Effect Of Drug Interaction On the Pharmacokinetics Of Vitami...mentioning

confidence: 99%

Pharmacokinetics of vitamin dosage forms: A complete overview

Sugandhi,

Pangeni,

Vora

et al. 2023

Food Science & Nutrition

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Vitamins are crucial for sustaining life because they play an essential role in numerous physiological processes. Vitamin deficiencies can lead to a wide range of severe health issues. In this context, there is a need to administer vitamin supplements through appropriate routes, such as the oral route, to ensure effective treatment. Therefore, understanding the pharmacokinetics of vitamins provides critical insights into absorption, distribution, and metabolism, all of which are essential for achieving the desired pharmacological response. In this review paper, we present information on vitamin deficiencies and emphasize the significance of understanding vitamin pharmacokinetics for improved clinical research. The pharmacokinetics of several vitamins face various challenges, and thus, this work briefly outlines the current issues and their potential solutions. We also discuss the feasibility of enhanced nanocarrier‐based pharmaceutical formulations for delivering vitamins. Recent studies have shown a preference for nanoformulations, which can address major limitations such as stability, solubility, absorption, and toxicity. Ultimately, the pharmacokinetics of pharmaceutical dosage forms containing vitamins can impede the treatment of diseases and disorders related to vitamin deficiency.

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Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial

Cited by 18 publications

References 28 publications

Fat-Soluble Vitamins in Standard vs. Liposomal Form Enriched with Vitamin K2 in Cystic Fibrosis: A Randomized Multi-Center Trial

Fat-Soluble Vitamins in Standard vs. Liposomal Form Enriched with Vitamin K2 in Cystic Fibrosis: A Randomized Multi-Center Trial

Nutritional Care in Children with Cystic Fibrosis

Pharmacokinetics of vitamin dosage forms: A complete overview

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