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
Keywords:Vitamin D, Nanoparticle, 25 (OH) D, Vitamin D deficiency
Background: In India more than 90% of apparently healthy Indians have subnormal 25(OH) D levels. To maintain sufficient vitamin D level, apart from sunlight and food containing vitamin D, supplementation with vitamin D is also required. The objective of this study was to find out effectiveness of nanoparticle based vitamin D formulations in patient of vitamin D deficiency and insufficiency
Methods: This was a prospective, open label, single arm, non-comparative, dose response post-marketing efficacy study (PMS) – phase-4 study to find the effectiveness of a nanoparticle based vitamin D formulation in adult patients between 18 to 65 years of either gender, attending/visiting the study site with documented deficiency or insufficiency of vitamin D (<30 ng/ml) or sign and symptoms of deficiency or insufficiency of vitamin D. Each subject planned to receive 60,000 IU of nanoparticle based vitamin D, once weekly, for 8 weeks orally. Serum 25(OH) D levels were measured at baseline, 4 and 8 week.
Results: The mean baseline serum 25[OH] D levels were 15.90. After treatment with nanoparticle based vitamin D there was a significant increase in the serum vitamin D levels at 4 weeks (41.03) and 8 weeks (31.38) (p<0.0001). Patients who have received treatment for at least 4 weeks’ period (n=38), the improvement (serum 25[OH] D >30 ng/ml) was seen in 84.2% patients (n=32) at the end of 4 weeks itself. There is significant increased (<0.0001) in the physical component scores of the SF-12 QOL questionnaire after 8 weeks of therapy.
Conclusions: Nanoparticle based formulation of vitamin D3 is effective and safe in correction of vitamin D levels in patients with documented deficiency or insufficiency of vitamin D. Also the safety and tolerability is well accepted and reported good to excellent by patients and physician.
Holick MF. Vitamin D: important for prevention of osteoporosis, cardiovascular heart disease, type 1 diabetes, autoimmune diseases, and some cancers. South Med J. 2005;98:1024–7.
Hollick MF. Vitamin D deficiency. N Engl J Med. 2007;357:266-81.
Goswami R, Gupta N, Goswami D, Marwaha RK, Tandon N, Kochupillai N. Prevalence and significance of low 25-hydroxyvitamin D concentrations in healthy subjects in Delhi. Am J Clin Nutr. 2000;72:472–5.
Vupputuri MR, Goswami R, Gupta N, Ray D, Tandon N, Kumar N. Prevalence and functional significance of 25-hydroxyvitamin D deficiency and vitamin D receptor gene polymorphisms in Asian Indians. Am J Clin Nutr. 2006;83:1411–9.
Harinarayan CV, Ramalakshmi T, Prasad UV, Sudhakar D, Srinivasarao PV, Sarma KV, et al. High prevalence of low dietary calcium, high phytate consumption, and vitamin D deficiency in healthy south Indians. Am J Clin Nut. 2007;85:1062–7.
Goswami R, Gupta N, Ray D, Singh N, Tomar N. Pattern of 25-hydroxy vitamin D response at short (2 month) and long (1 year) interval after 8 weeks of oral supplementation with cholecalciferol in Asian Indians with chronic hypovitaminosis D. Br J Nutr. 2008;100:526–9.
Mithal A. Vitamin D deficiency in India. Recommendation for prevention and treatment. Endocrine society of India Expert group. India : Elsevier; 2015.
Shah P, Kulkarni S, Narayani S, Sureka D, Dutta S, Vipat AS, et al. Prevalence Study of Vitamin D Deficiency and to Evaluate the Efficacy of Vitamin D3 Granules 60,000 IU Supplementation in Vitamin D Deficient Apparently Healthy Adults. Indian J Clin Practice. 2013;23(12):827-32.
Awumey EM, Mitra DA, Hollis BW, Kumar R, Bell NH. Vitamin D metabolism is altered in Asian Indians in the southern United states: a clinical research center study. J Clin Endocrinol Metab. 1998;83:169-73.
Babu US, Calvo MS. Modern India and the vitamin D dilemma: evidence for the need of a national food fortification program. Mol Nutr Food Res. 2010;54:1134-47.
Londhey V. Vitamin D Deficiency: Indian Scenario. J Assoc Physicians India. 2011;59:695-6.
Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008;87:1080–6.
Malhotra N, Mithal A, Gupta S, Shukla M, Godbole M. Effect of vitamin D supplementation on bone health parameters of healthy young Indian women. Arch Osteoporos. 2009;4(1-2):47-53.
Holick MF. Vitamin D. In Modern Nutrition in Health and Disease. In: Shils ME, Shike M, Ross AC, Caballero B, Cousins RJ, editors. 10th edition. Hagerstown MD: Lippincott Williams & Wilkins; 2006: 376–395.
Vieth R. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. Am J Clin Nutr. 1999;69:842–56.
Viljakainen HT, Palssa A, Ka¨rkka¨inen M, Jakobsen J & Lamberg-Allardt C. How much vitamin D3 do the elderly need? J Am Coll Nutr. 2006;25:429–35.
Kennel KA, Drake MT, Hurley DL. Vitamin D Deficiency in Adults: When to Test and How to Treat. Mayo Clin Proc. 2010;85(8):752–8.
Basu TK, Donaldson D. Intestinal absorption in health and disease: micronutrients. Best Pract Res Clin Gastroenterol. 2003;17:957–79.
Bothiraja C, Pawar A, Deshpande G. Ex-vivo absorption study of a nanoparticle based novel drug delivery system of vitamin D3 (Arachitol NanoTM) using everted intestinal sac technique. J Pharma Investigation. 2016;46:425–32.
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 Cells, Blood Substitutes, and Biotechnology. 2012;40(1-2):113-9.
Rautureau M, Rambaud JC. Aqueous solubilization of vitamin D3 in normal man. Gut. 1981;22:393-7.
Bruno S. Oral insulin delivery by means of solid lipid nanoparticles. Int J Nanomedicine. 2007;2(4):743-9.
Luo Y. Development of zein nanoparticles coated with carboxymethyl chitosan for encapsulation and controlled release of vitamin D3. J Agric Food Chem. 2012;60(3):836-43.
Mazahery H, von Hurst PR. Factors Affecting 25-Hydroxyvitamin D Concentration in Response to Vitamin D Supplementation. Nutrients. 2015;7(7):5111–42.
Blum M, Dolnikowski G, Seyoum E, Harris SS, Booth SL, Peterson J, et al. Vitamin D(3) in fat tissue. Endocrine. 2008;33(1):90-4.
Chen JS, Sambrook PN, March L, Cameron ID, Cumming RG, Simpson JM, et al. Hypovitaminosis D and parathyroid hormone response in the elderly: effects on bone turnover and mortality. Clin Endocrinol (Oxf). 2008;68(2):290-8.
Isaia G, Giorgino R, Rini GB, Bevilacqua M, Maugeri D, Adami S. Prevalence of hypovitaminosis D in elderly women in Italy: clinical consequences and risk factors. Osteoporos Int. 2003;14(7):577-82.
MacLaughlin J, Holick MF. Aging decreases the capacity of human skin to produce vitamin D3. J Clin Investig. 1985;76:1536–8.
Pop CL, Chang B, Wang X, Wei S, Shapses SA. Bone and Mineral Metabolism; Vitamin D Metabolism and Action. Estrogen, vitamin D binding protein and 25-hydroxyvitamin D in healthy women and men. Washington, DC, USA: Endocrine Society; 2014: 31.
Song HR, Kweon SS, Choi JS, Rhee JA, Lee YH, Nam HS, et al. High prevalence of vitamin D deficiency in adults aged 50 years and older in Gwangju, Korea: the Dong-gu Study. J Korean Med Sci. 2014;29(1):149–52.
Kung AW, Lee KK. Knowledge of vitamin D and perceptions and attitudes toward sunlight among Chinese middle-aged and elderly women: a population survey in Hong Kong. BMC Public Health. 2006;6:226.
Gangadhar A. A novel, nanoparticle based liquid oral formulation of Vitamin D3 for managing vitamin D deficiency: A survey of doctor’s preferences and practices in India. The Indian Practitioner. 2016;69:26-31.