A PROSPECTIVE COMPARATIVE STUDY ON EFFICACY OF ORAL VITAMIN D FORMULATIONS IN PATIENTS WITH CHRONIC LOW BACK PAIN WITH VITAMIN D DEFICIENCY AT A TERTIARY CARE HOSPITAL

K. SANTHA BAI; D. JAYASREE; BHARATHI UPPU; SOWMYA DEEPTHI C.

doi:10.22159/ijcpr.2024v16i2.4031

Authors

K. SANTHA BAI Department of Pharmacology, Government Medical College Nandyal, Andhra Pradesh, India https://orcid.org/0009-0003-9578-9410
D. JAYASREE Department of Pharmacology, Government Medical College Nandyal, Andhra Pradesh, India
BHARATHI UPPU Department of Pharmacology, Sri Venkateswara Medical College, Tirupati, Andhra Pradesh, India
SOWMYA DEEPTHI C. Department of Pharmacology, Government Medical College Nandyal, Andhra Pradesh, India https://orcid.org/0009-0003-0530-9576

DOI:

https://doi.org/10.22159/ijcpr.2024v16i2.4031

Keywords:

Chronic low back pain, Vitamin D, Granules, Nano syrup, Soft gel

Abstract

Objective: Chronic low back pain is a global health problem with significant medical and economic burden. Vitamin D deficiency and obesity are its risk factors. The objective was to determine efficacy of oral vitamin D formulations in patients with chronic low back pain with vitamin D deficiency.

Methods: A prospective analytical cohort study was conducted. Patients with self-reported chronic low back pain and with vitamin D concentrations ≤30 ng/dl were identified and randomized into 3 groups namely Granule, Nano syrup and soft gel capsule group. Vitamin D supplementation of 60,000 IUs per dose for ten consecutive days was given in the form of granule (1 g sachet), Nano syrup (5 ml bottle) and soft gel capsule. We measured (25-hydroxyvitamin D [25(OH)D]) concentrations and to assess pain, Visual analogue scale and Modified Oswestry low back pain disability questionnaire (MODQ) were used before and 12 w after the intervention.

Results: After 12 w 25(OH)D levels increased significantly with vitamin D supplementation in all the groups but more in the Nano syrup group. There was also significant reduction in back pain intensity in all the groups after vitamin D supplementation. However in Nano syrup group, there was a significantly greater reduction in back pain compared with other groups.

Conclusion: Our findings suggest that vitamin D supplementation in vitamin D deficient adults may improve chronic low back pain. Hence, testing for vitamin D deficiency in those with chronic low back pain may be warranted.

Downloads

Download data is not yet available.

References

Bansal D, Asrar Mir Mahmood, Ghai Babita, Pushpendra D. Prevalence and impact of low back pain in a community-based population in Northern India. Pain Phys. 2020;23(4):E389-98. PMID 32709185.

Ganesan S, Shankar Acharya A, Chauhan R, Acharya S. Prevalence and risk factors for low back pain in 1,355 young adults: a cross-sectional Study Asian Spine J. 2017 Aug;11(4):610-7. doi: 10.4184/asj.2017.11.4.610, PMID: 28874980.

Ekman M, Jonhagen S, Hunsche E, Jonsson L. Burden of illness of chronic low back pain in sweden: a cross-sectional, retrospective study in primary care setting. Spine. 2005;30(15):1777-85. doi: 10.1097/01.brs.0000171911.99348.90, PMID 16094281.

Wacker M, Holick MF. Sunlight and vitamin D: a global perspective for health. Dermatoendocrinol. 2013;5(1):51-108. doi: 10.4161/derm.24494, PMID 24494042.

Badley EM, Rasooly I, Webster GK. Relative importance of musculoskeletal disorders as a cause of chronic health problems, disability, and health care utilization: findings from the 1990 Ontario Health Survey. J Rheumatol. 1994;21(3):505-14. PMID 8006895.

Loney PL, Stratford PW. The prevalence of low back pain in adults: A methodological review of the literature. Phys Ther. 1999;79(4):384-96. doi: 10.1093/ptj/79.4.384, PMID 10201544.

Koley S, Sandhu NK. An association of body composition components with the menopausal status of patients with low back pain in tarn Taran, Punjab, India. Journal of Life Sciences. 2009;1(2):129-32. doi: 10.1080/09751270.2009.11885144.

Meucci RD AG, Paniz VM, Silva MC, Wegman DH. Increase of chronic low back pain prevalence in a medium-sized city of southern Brazil. BMC Musculoskelet Disord. 2013;14:155. doi: 10.1186/1471-2474-14-155.

Silva MC, Fassa AG, Valle NC. Chronic low back pain in a Southern Brazilian adult population: prevalence and associated factors. Cad Saude Publica. 2004;20(2):377-85. doi: 10.1590/s0102-311x2004000200005, PMID 15073617.

Badsha H, Daher M, Ooi Kong K. Myalgias or non-specific muscle pain in Arab or Indo-Pakistani patients may indicate vitamin D deficiency. Clin Rheumatol. 2009;28(8):971-3. doi: 10.1007/s10067-009-1146-7, PMID 19277814.

Rosen CJ, Adams JS, Bikle DD, Black DM, DeMay MB, Manson JE. The nonskeletal effects of vitamin D: an endocrine society scientific statement. Endocr Rev. 2012;33(3):456-92. doi: 10.1210/er.2012-1000, PMID 22596255.

Charoenngam N, Holick MF. Immunologic effects of vitamin D on human health and disease. Nutrients. 2020;12(7):2097. doi: 10.3390/nu12072097, PMID 32679784.

Mora JR, Iwata M, Von Andrian UH. Vitamin effects on the immune system: vitamins A and D take centre stage. Nat Rev Immunol. 2008;8(9):685-98. doi: 10.1038/nri2378, PMID 19172691.

van Etten E, Stoffels K, Gysemans C, Mathieu C, Overbergh L. Regulation of vitamin D homeostasis: implications for the immune system. Nutr Rev. 2008;66(10) Suppl 2:S125-34. doi: 10.1111/j.1753-4887.2008.00096.x, PMID 18844839.

Buell JS, Dawson Hughes B. Vitamin D and neurocognitive dysfunction: preventing ”D”ecline? Mol Aspects Med. 2008;29(6):415-22. doi: 10.1016/j.mam.2008.05.001, PMID 18579197.

Calton EK, Keane KN, Newsholme P, Soares MJ. The impact of vitamin D levels on inflammatory status: a systematic review of immune cell studies. Plos One. 2015;10(11):e0141770. doi: 10.1371/journal.pone.0141770, PMID 26528817.

Holick MF. Vitamin D deficiency. N Engl J Med. 2007;357(3):266-81. doi: 10.1056/NEJMra070553, PMID 17634462.

Wacker M, Holick MF. Vitamin D-effects on skeletal and extraskeletal health and the need for supplementation. Nutrients. 2013;5(1):111-48. doi: 10.3390/nu5010111, PMID 23306192.

Haussler MR, Whitfield GK, Kaneko Ichiro, Forster Ryan, Saini Rimpi, Hsieh Jui-Cheng. The role of vitamin D in the FGF23, klotho, and phosphate bone-kidney endocrine axis. Rev Endocr Metab Disord. 2012 Mar;13(1):57-69. doi: 10.1007/s11154-011-9199-8, PMID 21932165.

Bikle DD, Zolock DT, Morrissey RL, Herman RH. Independence of 1,25-dihydroxyvitamin D3-mediated calcium transport from de novo RNA and protein synthesis. J Biol Chem. 1978 Jan;253(2):484-8. doi: 10.1016/S0021-9258(17)38235-2, PMID 618881.

Cauley JA, Parimi N, Ensrud Kristine Kristine E, Bauer Douglas Douglas C, Cawthon Peggy Peggy M, Cummings Steven Steven R. Serum 25-hydroxyvitamin D and the risk of hip and nonspine fractures in older men. J Bone Miner Res. 2010;25(3):545-53. doi: 10.1359/jbmr.090826, PMID 19775201.

Holick MF, Binkley NC, Bischoff Ferrari Heike Heike A, Gordon Catherine Catherine M, Hanley David David A, Heaney Robert Robert P, Connie M. Weaver Endocrine society. Evaluation, treatment, and prevention of vitamin D deficiency: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(7):1911e1930.

Shipton EE. Vitamin D and pain: vitamin d and its role in the aetiology and maintenance of chronic pain states and associated comorbidities. Pain Res Treat. 2015. doi: 10.1155/2015/904967, PMID: 26090221.

Institute of Medicine, Food and Nutrition Board. Dietary reference intakes for calcium and vitamin D. Washington, DC: National Academy Press; 2010.

Walia N, Dasgupta N, Ranjan S, Chen L, Ramalingam C. Fish oil based vitamin D nanocapsulation by ultrasonication and bioaccessibility analysis in simulated gastrointestinal tract. Ultrason Sonochem. 2017;171:623-35.

Gupta R, Behera C, Paudwal G, Rawat N, Baldi A, Gupta PN. Recent advances in formulation strategies for efficient delivery of vitamin D. AAPS PharmSciTech. 2018;20(1):11. doi: 10.1208/s12249-018-1231-9, PMID 30560516.

Al Faraj S, Al Mutairi K. Vitamin D deficiency and chronic low back pain in Saudi Arabia. Spine. 2003;28(2):177-9. doi: 10.1097/00007632-200301150-00015, PMID 12544936.

Berridge MJ. Vitamin D and depression: cellular and regulatory mechanisms. Pharmacol Rev. 2017;69(2):80-92. doi: 10.1124/pr.116.013227, PMID 28202503.

Goswami R, Gupta N, Ray D, Singh N, Tomar N. Pattern of 25-hydroxy vitamin D response at short (2 mo) and long (1 y) interval after 8 w of oral supplementation with cholecalciferol in Asian Indians with chronic hypovitaminosis D. Br J Nutr. 2008;100(3):526-9. doi: 10.1017/S0007114508921711.

Rkain H, Bouaddi I, Ibrahimi A, Lakhdar T, Abouqal R, Allali F. Relationship between vitamin D deficiency and chronic low back pain in postmenopausal women. Curr Rheumatol Rev. 2013;9(1):63-7. doi: 10.2174/1573397111309010011, PMID 25198368.