Study design (if review, criteria of inclusion for studies)
Multi-center randomized controlled trial
100 pancreatic-insufficient patients with CF.
A liposomal fat-soluble vitamin formulation containing vitamin K2. 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.
The main outcome was the change of vitamin status in the serum during the study (liposomal vs. standard). The secondary outcome was the vitamin status at the trial end.
Forty-two patients finished the trial in the liposomal and 49 in the control group (overall 91 pts: 22.6 Â± 7.6 years, 62.6% female, BMI 19.9 Â± 2.8 kg/m(2), FEV1% 70% Â± 30%). The main outcome was the change of vitamin status in the serum during the study (liposomal vs. standard): all-trans-retinol (+1.48 Â± 95.9 vs. -43.1 Â± 121.4 ng/mL, p = 0.054), 25-hydroxyvitamin D3 (+9.7 Â± 13.4 vs. +2.0 Â± 9.8 ng/mL, p = 0.004), Î±-tocopherol (+1.5 Â± 2.5 vs. -0.2 Â± 1.6 Âµg/mL, p < 0.001), %undercarboxylated osteocalcin (-17.2 Â± 24.8% vs. -8.3 Â± 18.5%, p = 0.061). The secondary outcome was the vitamin status at the trial end: all-trans-retinol (370.0 Â± 116.5 vs. 323.1 Â± 100.6 ng/mL, p = 0.045), 25-hydroxyvitamin D3 (43.2 Â± 16.6 vs. 32.7 Â± 11.5 ng/mL, p < 0.001), Î±-tocopherol (9.0 Â± 3.1 vs. 7.7 Â± 3.0 Âµg/mL, p = 0.037), %undercarboxylated osteocalcin (13.0 Â± 11.2% vs. 22.7 Â± 22.0%, p = 0.008).
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.