A randomised controlled trial comparing the efficacy of micellised and fat-soluble vitamin D₃ supplementation in healthy adults

Abstract

Nanoemulsion formulation of vitamin D3 have been shown to have better bioavailability than the coarse emulsion preparation in vitro and in vivo animal studies. In the absence of randomised trial in humans, comparing the efficacy of nanotechnology-based miscellised vitamin D3 over conventional vitamin D3, we undertook this study. A total of 180 healthy adults were randomised to receive either micellised (DePura, group A) or conventional vitamin D3 (Calcirol, group B) at a monthly dose of 60 000 IU (1500μg) for 6 months. The outcome parameters were serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone (PTH), Ca, phosphate, alkaline phosphatase and urinary Ca:creatinine ratio. A total of eighty-nine subjects in group A and seventy-seven in group B completed the trial. Subjects in both the groups had a significant increase in their serum 25(OH)D levels following supplementation (group A: 21·5 (sd 10·9) to 76·7 (sd 18·8) nmol/l (P<0·001); group B: 22·8 (sd 10·4) to 57·8 (sd 16·0) nmol/l (P<0·001)). Participants in micellised group had an additional increase of 20·2 (95 % CI 14·0, 26·4) nmol/l in serum 25(OH)D levels (P<0·001). The difference between the groups was 17·5 (95 % CI 11·8, 23·1) nmol/l, which remained statistically significant (P<0·001) even after adjustment for age and sex. Significant decline in mean serum PTH was observed in both the groups. No hypercalcaemia or hypercalciuria was noted. Although supplementation with both the preparations resulted in a significant rise in serum 25(OH)D levels, micellised vitamin D3 appeared to be more efficacious in achieving higher levels of serum 25(OH)D.

Efficacy and safety of various oral regimens (three oral doses) and schedules (daily v. monthly) of cholecalciferol in North Indian adults with low vitamin D status: evidence from a randomised controlled trial

“…VD sufficiency achieved in 90% subjects with monthly dose of 60,000 IU is more or less similar (95%) to that achieved with oral dose of 2000 IU/day, though with a higher increase in serum 25(OH)D concentration in group C. This finding is supported by reports from Niet et al in adults 29 and Marwaha et al 37 among others 31,[38][39][40] who documented 100% and 90% subjects attaining serum 25(OH)D concentration >20 ng/ml respectively with 60,000 IU and 50,000 IU oral monthly doses. These results assume significance in view of the fact that once monthly cholecalciferol supplementation may be convenient for people and ensure better compliance.…”

“…In India, there is a lack of clear-cut data on the optimal dose/schedule of VD supplementation to achieve serum 25(OH)D >20 ng/ml, owing to heterogeneity of the studies about age, duration (8 weeks to 1 year), doses (200 to 60,000 IU), sample size, level of serum 25(OH)D considered sufficient and populations studied [13][14][15][16] . Hence, we undertook this randomized study with to evaluate the comparative effectiveness of three different daily dosage regimens of oral cholecalciferol supplementation among themselves and with once-monthly schedule.…”

Efficacy and Safety of Vitamin D3 (Cholecalciferol) Oral Solution Compared to Tablet and Capsule: A Randomized, Parallel-Design, Active-Controlled Study

“…The bioavailability of nutrients that have poor water solubility can be increased by nanotechnology (11,20). Evidence showed that nanoparticles of vitamin D 3 might also enhance important properties of vitamin D supplements, like therapeutic efficacy, photo-stability, and biodegradation (21). Moreover, in our previous study, we have compared the bioequivalence of vitamin D 3 oral solution with that of conventional vitamin D 3 tablets and capsules.…”

Postprandial 25-hydroxyvitamin D response varies according to the lipid composition of a vitamin D3 fortified dairy drink

“…Other in-vitro research shows potential to improve absorption by incorporating fat soluble vitamins within a micelle before consumption (Goncalves et al 2013). Building on this in-vitro work, Marwaha and colleagues report greater increases in 25(OH)D with a water micellised vitamin D supplement compared to a conventional vitamin D supplement in children and adults (Marwaha et al 2016(Marwaha et al , 2019. Similarly.…”