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Comparative efficacy analysis of micellised and fat-soluble Vitamin D3 supplementation in Healthy adults

In comparison of in aqueous fluids, vitamin D is a non-polar lipid with limited bioavailability and low solubility and studies conducted in vivo indicate that formulations based on nanotechnology have higher bioavailability than traditional formulations. According to the findings, a further statistically significant (p<0.001) even after adjusting for age and gender, observed increase of 20.2 nmol/l in serum 25 (OH)D levels was attained by patients in the micellised group. 

Other biochemical markers changed similarly in both groups, with the exception of serum phosphate, which rose from 1.05 to 1.17 mmol/l in micellised formulations vs. 1 to 1.11 mmol/l in conventional formulations (p<0.012). The absence of metabolic problems in any of the patients suggests that the micellised formulation is tolerated. The stearic barrier and the nanoparticles' tiny size, which prevent adsorption and promote bioavailability, may be the cause of the micellised formulation's superior performance.

Results1

Figure 1: Effect of micellised vs conventional formulations on serum 25(OH)D levels

Patients in the micellised group achieved an additional statistically significant (p< 0.001) increase of 20·2 nmol/l in serum 25 (OH)D levels The difference was statistically significant even with the age and sex adjustments (17·5 nmol/l, p < 0.001).

Figure 2: Percentage of patients achieving adequate serum levels

Figure 3: Effect of micellised vs conventional formulations on PTH levels and hyperparathyroidism

The changes in other biochemical parameters were similar in both the groups except for serum phosphate, which increased from 1·05 to 1·17 mmol/l in micellised formulation vs 1 to 1.11 mmol/l in conventional formulations p< 0.012

None of the patients developed metabolic disorders suggesting the tolerability of micellised formulation

Serum Vitamin D3 Test

The better effcacy of micellised formulation might be due to the stearic barrier and small size of the nanoparticles that hamper the adsorption and increase the bioavailability.

25(OH)D - 25-hydroxyvitamin D; PTH - parathyroid hormone; Ca – calcium

Reference

  1. Marwaha RK, Dev T, Mittal A, Mani K, Narang A, Arora P, et al. A randomised controlled trial comparing the efficacy of micellised an fat-soluble vitamin D3 supplementation in healthy adults. Br J Nutr. 2019 Apr;121(8):859–865.

Study details

Marwaha 2019 - A randomized controlled trial conducted in three public schools and two government organizations in New Delhi. The trial included vitamin D deficient patients (n=166). The patients received either micellised or conventional formulation for 6 months.

MAT-IN-2301309 V1.0 06/23