Efficacy of Topiramate Alone and Topiramate Plus Vitamin D3 in the Prophylaxis of Pediatric Migraine: A Randomized Clinical Trial
Iranian Journal of Child Neurology,
Vol. 14 No. 4 (2020),
1 October 2020
,
Page 77-86
https://doi.org/10.22037/ijcn.v15i1.18017
Abstract
Objective
Topiramate is effective in the prevention of pediatric migraine, and studies show that vitamin D3 supplementation might also be useful in the treatment of adult migraineurs with a normal vitamin D3 level.
The present study aimed at comparing the efficacy and safety of topiramate plus vitamin D3 and topiramate alone in the prophylaxis of pediatric migraine.
Materials & Methods
In a single-blinded, randomized, clinical trial, 5-15-year-old children with migraine headaches, referred to the Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from January 2016 to January 2017, were randomly allocated to receive 2 mg/kg/day of topiramate or 2 mg/kg/day of topiramate plus one 500,000 IU vitamin D3 pearl weekly for two consecutive months.
Primary outcomes were the reduction of monthly frequency, severity, duration, and the disability score of migraine, and the secondary outcomes included a good response to treatment (more than 50% reduction in monthly headache frequency) and a lack of clinical adverse events.
Results
Totally, 31 female and 26 male children with the mean age of 10.02±2.11 years were evaluated. Both drugs were effective in the reduction of monthly frequency, severity, duration, and disability for headaches. Nevertheless, the combination of topiramate and vitamin D3 was more effective than topiramate alone in reducing the monthly headaches frequency (6.12±1.26 vs. 9.87±2.44 times, P=0.01) and disability score (19.24±6.32 vs. 22.11±7.91, P=0.02). Good response to treatment was observed in 60.7% and 75.9% of the subjects in the topiramate alone and topiramate plus vitamin D3 groups, respectively, and topiramate plus vitaminD3 was more effective (P= 0.01). Transient mild side effects were observed in 14.3% and 17.2% of the subjects in the topiramate alone and topiramate plus vitamin D3 groups, respectively (P=0.8).
Conclusion
A combination of Topiramate and vitamin D3 might be considered safe and more effective than Topiramate alone in the prophylaxis of pediatric migraine.
- Migraine
- Child
- Prevention
- Vitamin D3
- Topiramate
How to Cite
References
References
Hershey AD,Kabbouche MA, O'Brien HL. Migraine. Kliegman RM, Stanton BF, Schor NF, St. Geme JW, Behrman RE. Nelson Textbook of Pediatrics. Philadelphia, Saunders 2016; 20 th edition, Pp: 2866-73.
Kacperski J, Hershey AD. Newly Approved Agents for the Treatment and Prevention of Pediatric Migraine. CNS Drugs 2016; 30(9):837–44.
Yoo IH, Kim W, Kim H, et al. Factors associated with favorable outcome of topiramate migraine prophylaxis in pediatric patients. J Clin Neurol 2017; 13(3):281-286.
Sangermani R, Boncimino A. The use of nutraceutics in children's and adolescent's headache. Neurol Sci 2017; 38(Suppl 1):121-124.
Mottaghi T, Askari G, Khorvash F, Maracy MR. Effect of Vitamin D supplementation on symptoms and C-reactive protein in migraine patients. J Res Med Sci 2015; 20(5):477-82.
Holick MF. Vitamin D deficiency. N Engl J Med 2007, 357:266– 281.
Prakash S, Shah ND. Chronic tension-type headache with vitamin D deficiency: Casual or causal association? Headache 2009; 49:1214–22.
Neyestani TR, Hajifaraji M, Omidvar N, et al. High prevalence of vitamin D deficiency in school-age children in Tehran, 2008: a red alert. Public Health Nutr 2012; 15(2): 324-30.
Nagata E, Fujii N, Hosomichi K, et al. Possible association between dysfunction of vitamin D binding protein (GC Globulin) and migraine attacks. PLoS One 2014,22;9(8): e105319.
Kjaergaard M, Eggen AE, Mathiesen EB, Jorde R. Association between headache and serum 25-hydroxyvitamin D: the Tromsø Study: Tromsø 6. Headache 2012; 52(10):1499-505.
Knutsen KV, Brekke M, Gjelstad S, Lagerløv P. Vitamin D status in patients with musculoskeletal pain, fatigue and headache: A cross-sectional descriptive study in a multi-ethnic general practice in Norway. Scand J Prim Health Care2010; 28:166–71.
Lippi G, Cervellin G, Mattiuzzi C. No evidence for an association of vitamin D deficiency and migraine: a systematic review of the literature. Biomed Res Int 2014;2014:827635.
Zandifar A, Masjedi SS, Banihashemi M, et al. Vitamin D status in migraine patients: a case-control study. Biomed Res Int 2014;2014:514782.
Mottaghi T, Khorvash F, Askari G, Maracy MR, Ghiasvand R, Maghsoudi Z, Iraj B. The relationship between serum levels of vitamin D and migraine. J Res Med Sci 2013; 18(Suppl 1):S66-70.
Togha M, Razeghi Jahromi S, Ghorbani Z, Martami F, Seifishahpar M. Serum Vitamin D Status in a Group of Migraine Patients Compared With Healthy Controls: A Case-Control Study. Headache 2018; 58(10):1530-1540.
Celikbilek A, Gocmen AY, Zararsiz G, Tanik N, Ak H, Borekci E, Delibas N. Serum levels of vitamin D, vitamin D-binding protein and vitamin D receptor in migraine patients from central Anatolia region. Int J Clin Pract 2014 ;68(10):1272-7.
Prakash S, Mehta NC, Dabhi AS, Lakhani O, Khilari M, Shah ND. The prevalence of headache may be related with the latitude: a possible role of Vitamin D insufficiency? J Headache Pain 2010; 11(4):301-7.
Gazerani P, Fuglsang R, Pedersen JG, et al. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D3 supplementation in adult patients with migraine. Curr Med Res Opin 2019; 35(4):715-723.
Buettner C, Nir RR, Bertisch SM, Bernstein C, Schain A, Mittleman MA, Burstein R. Simvastatin and vitamin D fr migraine prevention: A randomized, controlled trial. Ann Neurol 2015; 78(6):970-81.
Mottaghi T, Askari G, Khorvash F, Maracy MR.Effect of Vitamin D supplementation on symptoms and C-reactive protein in migraine patients. J Res Med Sci 2015;20(5):477-82.
Cayir A, Turan MI, Tan H.Effect of vitamin D therapy in addition to amitriptyline on migraine attacks in pediatric patients. Braz J Med Biol Res 2014 ;47(4):349-54.
Oleson J. The International Classification of Headache Disorders: 2nd edition. Headache Classification Subcommittee of the International Headache Society. Cephalalgia 2004; 24, Suppl 1:9-160.
Hershey AD, Powers SW, Vockell ALB, LeCates SL, Kabbouche MA, Maynard MK. PedMIDAS: Development of a questionnaire to assess disability of migraines in children. Neurology 2001; 57:2034-2039.
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health 1990; 13: 227-36.
Wheeler S. Vitamin D deficiency in chronic migraine. Headache. 2008; 48:S52–S53.
Aydin FN, Aydin I, Agilli M. Comment on "Vitamin D status in migraine patients: a case-control study". Biomed Res Int. 2014; 2014:635491.
Motaghi M, Haghjooy Javanmard S, Haghdoost F, Tajadini M, Saadatnia M, Rafiee L, Zandifar A. Relationship between vitamin D receptor gene polymorphisms and migraine without aura in an Iranian population. Biomed Res Int 2013; 2013:351942.
Straube S, Andrew Moore R, Derry S, McQuay HJ. Vitamin D and chronic pain. Pain 2009; 141(1–2):10–13.
Prakash S, Shah ND. Chronic tension-type headache with vitamin D deficiency: casual or causal association? Headache 2009; 49(8):1214–1222.
Arantes HP, Kulak CA, Fernandes CE, Zerbini C, Bandeira F, Barbosa IC, et al. Correlation between 25-hydroxyvitamin D levels and latitude in Brazilian postmenopausal women: from the Arzoxifene Generations Trial. Osteoporos Int 2013; 24: 2707-2712.
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