Clinical study of the tolerability of calcium carbonate–casein microcapsules as a dietary supplement in a group of postmenopausal women

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Abstract

Background: Calcium is an essential macronutrient; however, currently supplements are often associated with gastrointestinal (GI) adverse events. The authors investigated the tolerability of a new delivery system for calcium supplementation, based on the functionalization of calcium carbonate (CaCO3) particles by casein proteins, in a randomized, prospective, double-blind, active comparator clinical trial.

Methods: Around 208 postmenopausal women were enrolled and randomized 1:1:1:1 to one of the four calcium supplements, taken for 30 days: (1) microencapsulated CaCO3 (microCaCO3) with a 90:10 mineral to protein ratio; (2) microCaCO3 with a 95:5 mineral to protein ratio; (3) conventional CaCO3 tablets; and (4) calcium citrate tablets (CaCitr). The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire was used to evaluate the GI tolerability and the Treatment Satisfaction Questionnaire for Medication (TSQM) to analyze the satisfaction of the participants with the use of the calcium supplements.

Results: The mean GSRS scores at baseline differed among the groups from 3.95 to 5.35 without statistical significance. After 1 month use of supplements, the group given microCaCO3 with a 90:10 mineral to protein ratio, showed the lowest mean GSRS score (6.07), while the group given conventional CaCO3 showed the highest score (11.86). According to the completed TSQM questionnaire, the use of supplements was easier for both microCaCO3 groups in comparison with conventional supplements.

Conclusions: The microCaCO3 supplement has shown promising results in the context of GI tolerability and patient satisfaction in the use of supplements compared to conventional calcium supplements. The reduction of GI adverse events may increase the compliance to calcium supplements especially important among groups at risk of calcium deficiency.

Keywords: casein-functionalized calcium carbonate microcapsules, dietary calcium supplements, gastrointestinal adverse events, microencapsulated calcium carbonate, postmenopausal women.

Citation: Palacios S, Ramirez M, Lilue M. Clinical study of the tolerability of calcium carbonate–casein microcapsules as a dietary supplement in a group of postmenopausal women. Drugs in Context 2020; 9: 2020-1-4. DOI: 10.7573/dic.2020-1-4

Contributions: All authors contributed extensively to the work presented in this paper. All authors have contributed significantly to the conception, design, or acquisition of data, or analysis and interpretation of data. All authors have participated in in drafting, reviewing, and/ or revising the manuscript and have approved its submission. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: This work was supported by Nexentia S.A.S. The authors have no other conflict of interest. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at https://www.drugsincontext.com/wp-content/uploads/2020/03/dic.2020-1-4-COI.pdf

Acknowledgements: The authors would like to thank to Dr Herley Casanova and Msc Jorge Jaimes (Colloids Group, University of Antioquia, Medellín, Colombia) for providing SEM and TEM images and relevant physicohemical properties of calcium carbonate microcapsules. Writing and editorial assistance was provided by Content Ed Net (Madrid, Spain).

Funding declaration: This work was supported by Colciencias-Sumicol S.A., University of Antioquia Grant 1115-562-38446 Cto 0162-2014 and Nexentia S.A.S. Writing and editorial assistance was funded by Nexentia S.A.S.

Copyright: Copyright © 2020 Palacios S, Ramirez M, Lilue M. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2020 Palacios S, Ramirez M, Lilue M. https://doi.org/10.7573/dic.2020-1-4. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/clinical-study-of-the-tolerability-of-calcium-carbonate-casein-microcapsules-as-a-dietary-supplement-in-a-group-of-postmenopausal-women

Correspondence: Santiago Palacios, Palacios Institute of Women´s Health, Calle Antonio Acuña, 9, CP. 28009, Madrid, Spain. spalacios@institutopalacios.com

Provenance: submitted; externally peer reviewed.

Submitted: 31 January 2020; Peer review comments to author: 20 February 2020; Revised manuscript received: 19 March 2020; Accepted: 20 March 2020; Publication date: 23 April 2020.

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