Clinical efficacy of different dosage forms containing vitamin D: design and study outcomes of a randomized, comparative clinical trial
DOI:
https://doi.org/10.18203/2349-3259.ijct20203104Keywords:
Vitamin D, Orally disintegrating strips, 25-hydroxy Vitamin D, Ergocalciferol, Cholecalciferol, 25(OH)D3Abstract
Background: Different dosage forms of vitamin D like tablets, soft gelatin capsules, oral granules, powders, solutions and thin films are available. The objective of the present study was to evaluate and compare the clinical efficacy of three different dosage forms of vitamin D3 namely, orally disintegrating strips, oral granules and oral solution.
Methods: An open label, single centre, prospective, randomized, parallel group, comparative study was conducted for a period of 4 months. The study participants were divided into three groups (A, B, C) and received the respective treatments (orally disintegrating strips, n=20; granules, n=20; oral nano solution, n=10) for the study period. The estimation of blood levels of 25-hydroxy vitamin D [25(OH)D3] in all the subjects at day 0, 60 and 120 was carried out.
Results: The normalization level of 25(OH)D3 achieved by the subjects in group A, group B and group C was 100%, 83.3% and 90% respectively after 90 days. Comparison of 25(OH)D3 level in all three groups showed significant increase at day 60. The levels were maintained at day 90 and 120 even after drastic reduction in dosage in Group A and group C. On day 120, the dose reduction was in the order of group A>group C>group B.
Conclusions: All the three formulations showed increase in the level of 25(OH)D3. It can be concluded that oral disintegrating strips of 25(OH)D3 are clinically more efficient than other conventional dosage forms.
References
Bjelakovic G, Gluud L, Nikolova D, Whitfield K, Wetterslev J, Simonetti R, et al. Vitamin D supplementation for prevention of mortality in adults. Cochrane Database Syst Rev. 2011;CD007470.
Carter Graham D. Accuracy of 25-hydroxyvitamin D assays: confronting the issues. Current Drug Targets. 2011;12(1):19-28.
Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol. 2009;19:73-8.
Holick MF. Vitamin D deficiency. New Engl J Med. 2007;357:266-81.
Jane A, Harold H, Joseph T, Mike L, Mike H, Robert C. Biochemical efficacy and safety trial of vitamin D (BEST-D): finding an appropriate dose to test in a large randomized trial. Trials. 2013;14(1):45.
Wang X, Li W, Zhang Y, Yang Y, Qin G. Association between vitamin D and non-alcoholic fatty liver disease/non-alcoholic steatohepatitis: results from a meta-analysis. Int J Clin Exp Med. 2015;8(10):1721-34.
Holick MF. Vitamin D and health: evolution, biologic functions, and recommended dietary intakes for vitamin D. Clin Rev Bone Miner Metab. 2009;7(1):2-19.
Adams JS, Hewison M. Update in Vitamin D. J Clin Endocrinol Metab. 2010;95(2):471-8.
Autier P, Boniol M, Pizot C, Mullie P. Vitamin D status and ill health: a systematic review. Lancet Diabetes Endocrinol. 2014;2(1):76–89.
Gaksch M, Jorde R, Grimnes G, Joakimsen R, Schirmer H, Wilsgaard T et al. Vitamin D and mortality: individual participant data meta-analysis of standardized 25-hydroxyvitamin D in 26916 individuals from a European consortium. PLoS One. 2017;12(2):e0170791.
Khadilkar AV. Vitamin D deficiency in Indian adolescents. Indian Pediatr. 2010;47(9):755-6.
Londhey V. (Editorial) Vitamin D deficiency: Indian scenario. J Assoc Physicians India. 2011;59:695-6.
Misra M, Pacaud D, Petryk A, Collett-Solberg PF, Kappy M. Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society. Vitamin D deficiency in children and its management: Review of current knowledge and recommendations. Pediatrics. 2008;122(2):398-417.
Wagner CL, Greer FR. American Academy of Pediatrics Section on Breastfeeding, American Academy of Pediatrics Committee on Nutrition. Prevention of rickets and Vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008;122:1142-52.
Dixit R, Puthli S. Oral strip technology: Overview and future potential. J Controlled Release. 2009;139:94-107.
Barnhart SD, Sloboda MS. The future of dissolvable films. Drug Delivery Technol. 2007;7(8):34-7.
Nandgaye KM, Samant RS, Kadam SB, Palkar PJ. Relative oral bioavailability of three formulations of vitamin D3: an open-label, three-treatment study. Int J Basic Clin Pharmacol. 2019;8:138-42.
Manek KA. Evaluation of efficacy of a nanoparticle-based vitamin D formulation in correction of vitamin D levels in patients with documented deficiency or insufficiency of vitamin D. Int J Res Orthop. 2017;3(3):486-91.
Sun F, Ju C, Chen J, Liu S, Liu N, Wang K, et al. Nanoparticles based on hydrophobic alginate derivative as nutraceutical delivery vehicle: vitamin D3 loading. Artificial Cell, Blood Substitutes Biotech. 2012;40(1-2):113-9.
