2. Academic Validation
  3. 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

  • J Clin Med. 2022 Jan 17;11(2):462. doi: 10.3390/jcm11020462.
Jan Krzysztof Nowak 1,  Patrycja Krzyżanowska-Jankowska 1,  Sławomira Drzymała-Czyż 1 2,  Joanna Goździk-Spychalska 3,  Irena Wojsyk-Banaszak 4,  Wojciech Skorupa 5,  Ewa Sapiejka 6,  Anna Miśkiewicz-Chotnicka 1,  Jan Brylak 1,  Barbara Zielińska-Psuja 7,  Aleksandra Lisowska 1,  Jarosław Walkowiak 1
Affiliations

Affiliations

  • 1 Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.
  • 2 Department of Bromatology, Poznan University of Medical Sciences, Marcelinska 42, 60-354 Poznan, Poland.
  • 3 Department of Pulmonology, Allergology and Respiratory Oncology, Poznan University of Medical Sciences, Szamarzewskiego 84, 60-569 Poznan, Poland.
  • 4 Department of Pediatric Pneumonology, Allergology and Clinical Immunology, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.
  • 5 Department of Lung Diseases, Institute for Tuberculosis and Lung Diseases, Plocka 26, 01-138 Warsaw, Poland.
  • 6 The Specialist Centre for Medical Care of Mother and Child, Polanki 119, 80-308 Gdańsk, Poland.
  • 7 Department of Toxicology, Poznan University of Medical Sciences, Dojazd 30, 60-631 Poznan, Poland.
PMID: 35054157 DOI: 10.3390/jcm11020462
Abstract

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.

Keywords

cholecalciferol; cystic fibrosis; liposome; menaquinone; retinol; tocopherol; vitamin A; vitamin D; vitamin E; vitamin K.

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