Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial

J Am Coll Nutr. 2020 Jul;39(5):422-431. doi: 10.1080/07315724.2019.1684398. Epub 2019 Nov 20.

Abstract

Background: The efficacy of Vitamin C (L-ascorbic acid) supplementation can be assessed by uptake into the blood and retention in leukocytes. Vitafusion® Power C gummy is an alternative vitamin C source which may exhibit similar bioavailability to comparator caplets.Objective: The objective of this study was to evaluate the bioequivalence of vitamin C from a vitafusion® Power C gummy formulation and a comparator caplet in healthy adults.Methods: Thirty healthy men and women, 34.0 ± 11.4 years of age and Body Mass Index (BMI) 24.5 ± 3.6 kg/m2 completed the randomized examiner-blind, comparator controlled, cross-over trial with two sequences: gummy (1000 mg) to caplet (1000 mg) or caplet to gummy. Intake of foods fortified with Vitamin C was restricted 7 days prior to each dosing. Blood samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 h post-dose for plasma and leukocytes; and urine was collected pre-dose and between 0-2, 2-4, 4-8, 8-12 and 12-24 h post-dose for L-ascorbic acid analysis.Results: Vitafusion® Power C gummy and comparator caplet demonstrated similar plasma absorption profiles as there were no significant differences in plasma L-ascorbic acid total Area Under the Curve (AUC)0-24h, and Tmax between gummy and caplet. The caplet did elicit a significantly higher Cmax than the gummy (p < 0.05), however, the difference was numerically small. Leukocyte L-ascorbic acid total AUC0-24h and Cmax were not significantly different between gummy and caplet, however Tmax of the gummy group was significantly longer (p = 0.012). Urinary L-ascorbic acid levels were also not significantly different between gummy and caplet. There were no serious adverse events and safety parameters remained within normal clinical range for both products.Conclusion: Vitafusion® Power C gummy exhibited similar Vitamin C absorption and bioavailability to a comparator caplet in healthy adults and were considered bioequivalent.

Trial registration: ClinicalTrials.gov NCT03562988.

Keywords: L-ascorbic acid; Vitamin C; absorption; bioavailability; bioequivalence; multivitamin; vitafusion® Power C gummy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorption, Physiological
  • Administration, Oral
  • Adult
  • Area Under Curve
  • Ascorbic Acid / blood
  • Ascorbic Acid / pharmacokinetics*
  • Ascorbic Acid / urine
  • Biological Availability
  • Cross-Over Studies
  • Drug Compounding / methods*
  • Female
  • Healthy Volunteers
  • Humans
  • Leukocytes / chemistry
  • Male
  • Single-Blind Method
  • Therapeutic Equivalency
  • Vitamins / blood
  • Vitamins / pharmacokinetics*
  • Vitamins / urine

Substances

  • Vitamins
  • Ascorbic Acid

Associated data

  • ClinicalTrials.gov/NCT03562988