(P03-032-24) A RCT to Determine the Efficacy of Supplementing Nano D3 Buccal Spray vs Nano D3, Fat-Soluble D3 Tablet Daily for 3 Months in Vitamin D-deficient/Insufficient Indian Adults

Objectives: The use of nanotechnology to improve bioavailability of vitamin D3 preparations has been reported in vitro and in vivo studies. Given the absence of direct comparative studies, we conducted an open-label, randomized, controlled multicentric trial to assess the effectiveness of Nano D3 oral mucosal spray compared to Nano and conventional fat-soluble D3 tablets.

Methods: Of 324 subjects randomized into 4 groups, 298 apparently healthy adults were given daily supplementation of 1000 & 2000 IU of Nano D3 mucosal spray, tablet DenciumND3® (1000 IU Nano D3) and Tayo (1000 IU of conventional D3) preparations for 3 months. Baseline and post-supplementation serum 25(OH)D, PTH, 1,25(OH)₂D, Ca, PO4, ALP and urinary Ca/Cr ratio were evaluated as outcome indices.

Results: The mean age and BMI of subjects was 39.56±14.78 years and 25.65±4.19 respectively with no significant differences in baseline biochemical and hormonal parameters between the groups. Per-protocol analysis revealed a significant rise in serum 25(OH)D of 29.18, 23.54, 23.59 and 43.51 nmol/L post supplementation in all Groups A, B, C & D in compliant subjects (p < 0.001). However, the rise between Groups A & B, B & C and A & C who had received 1000 IU/day for three months was not significantly different from each other. No case of hypercalcemia was detected.

Conclusions: In conclusion, Oral mucosal D3 spray and Nano D3 tablets are equally effective in raising serum 25(OH)D levels and serve as suitable alternatives to tablet forms for individuals with malabsorption or swallowing difficulties.

Funding Sources: Different preparations of vitamin D3 were procured by Pulse Pharmaceuticals from the market and given for the trial. Funding for manpower, laboratory investigations etc was provided by the “Society for Endocrine Health of Elderly, Adolescent and Children” (SEHEAC), a non-profit organisation, New Delhi and Pulse Pharmaceuticals.