Bioequivalence Studies of Vitamin D Gummies and Tablets in Healthy Adults: Results of a Cross-Over Study.

Carol L. Wagner,Judy R. Shary,Amy E. Wahlquist,Paul J. Nietert,Myla D. Ebeling,Bruce W. Hollis

doi:10.3390/nu11051023

Carol L. Wagner, Judy R. Shary + Show 4 more

Open Access

https://doi.org/10.3390/nu11051023

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Journal: Nutrients	Publication Date: May 7, 2019
Citations: 11	License type: CC BY 4.0

Affiliation: Medical University of South Carolina

Abstract

The objective of this investigation was to compare bioavailability between single oral dose Vitamin D3 (vitD3) gummies vs. tablets in healthy adults. An initial crossover, randomized clinical trial involving healthy adults (n = 9) was conducted followed by a larger, confirmatory study (n = 31). Healthy participants aged 18–45 years with body mass index (BMI) 18–30 without anemia or vitD deficiency were randomized to receive 20,000 international units (IU) vitD3 as single dose gummies or tablets with serial samples obtained to measure plasma vitD3 at baseline, 3, 6, 10, 24, and 48 h followed by a 2-week washout period. The same participants then crossed over to receive 20,000 IU vitD3 in the form not previously given, with sampling at the same time points. Deidentified blood samples were analyzed for vitD3 concentration by liquid chromatography (LC)-mass spectroscopy. In Study 1, results suggested bioavailability was greater with gummies compared with tablets, (effect size 1.08 at 24 h). In Study 2, the area under the concentration curve (AUC) was higher with gummies than tablets (gummy mean (95% CI): 1474 ng·/mL (1393–1555); tablet mean (95% CI): 774 ng·h/mL (693–855), p < 0.0001). Average peak blood concentration (Cmax) values were significantly higher with gummies (gummy: 47.3 ng/mL; tablet: 23.4 ng/mL; p < 0.0001). VitD3 gummies had greater bioavailability than tablets with higher vitD concentrations over time, which may have implications for achieving vitD sufficiency.

Highlights

There is increasing evidence that vitamin D supplementation is essential in providing adequate delivery of this preprohormone implicated in calcium metabolism and in immune function [1,2]
The geometric mean for the vitamin D3 area under the concentration curve (AUC) curve was significantly different between the groups with higher concentrations following gummy ingestion when compared to tablet ingestion
There were statistically significant differences noted in bioavailability, with greater bioavailability with the gummy preparation compared to the tablet preparation

Summary

Introduction

There is increasing evidence that vitamin D supplementation is essential in providing adequate delivery of this preprohormone implicated in calcium metabolism and in immune function [1,2]. Supplementation is seen as a viable option to provide individuals with adequate vitamin D stores, yet compliance or adherence with vitamin D supplementation is often in question [5]. Difficulties with adherence in taking vitamin D tablets have been reported in other studies, compromising the results of intention to treat trial design [8,9,10]. In a focus group conducted by our group at the end of two vitamin D supplementation during pregnancy studies, participants shared that the types of pills taken impacted their adherence to taking the supplements. While vitamin D in the form of chewable tablets or gummies may improve adherence or compliance with taking daily vitamin D, the question has been posed if such formulations have similar bioequivalence and bioavailability to that of traditional tablet formulations

Methods

Results

Conclusion