Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Fall;14(4):77-86.

Efficacy of Topiramate Alone and Topiramate Plus Vitamin D3 in the Prophylaxis of Pediatric Migraine: A Randomized Clinical Trial

Razieh Fallah  1 , Saeedreza Sarraf Yazd  2 , Seid Mojtaba Sohrevardi  2
Affiliations

Efficacy of Topiramate Alone and Topiramate Plus Vitamin D3 in the Prophylaxis of Pediatric Migraine: A Randomized Clinical Trial

Razieh Fallah et al. Iran J Child Neurol. 2020 Fall.

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.

Keywords: Child; Migraine; Prophylaxis; Topiramate; Vitamin D3.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

  • Vitamin D receptor and binding protein genes variants in patients with migraine.
    García-Martín E, Navarro-Muñoz S, Ayuso P, Rodríguez C, Serrador M, Alonso-Navarro H, Calleja M, Espada-Rubio S, Navacerrada F, Turpín-Fenoll L, Recio-Bermejo M, García-Ruiz R, Millán-Pascual J, Plaza-Nieto JF, García-Albea E, Agúndez JAG, Jiménez-Jiménez FJ. García-Martín E, et al. Ann Clin Transl Neurol. 2023 Oct;10(10):1824-1832. doi: 10.1002/acn3.51872. Epub 2023 Aug 8. Ann Clin Transl Neurol. 2023. PMID: 37553799 Free PMC article.
  • Vitamin D in Neurological Diseases.
    Plantone D, Primiano G, Manco C, Locci S, Servidei S, De Stefano N. Plantone D, et al. Int J Mol Sci. 2022 Dec 21;24(1):87. doi: 10.3390/ijms24010087. Int J Mol Sci. 2022. PMID: 36613531 Free PMC article. Review.
  • Non-Pharmacological Treatments in Paediatric Migraine.
    Baglioni V, Bozza F, Beatrice A, Cameli N, Colacino Cinnante EM, Lentini G, Faedda N, Natalucci G, Guidetti V. Baglioni V, et al. J Clin Med. 2024 Feb 23;13(5):1278. doi: 10.3390/jcm13051278. J Clin Med. 2024. PMID: 38592096 Free PMC article. Review.
  • [Complementary and supplementary procedures in the treatment of headache].
    Gaul C, Zaranek L, Goßrau G. Gaul C, et al. Schmerz. 2023 Dec;37(6):448-460. doi: 10.1007/s00482-023-00738-1. Epub 2023 Jul 11. Schmerz. 2023. PMID: 37432483 Review. German.
  • Preventive Medications in Pediatric Migraine: A Network Meta-Analysis.
    Kohandel Gargari O, Aghajanian S, Togha M, Mohammadifard F, Abyaneh R, Mobader Sani S, Samiee R, Kermanpour A, Seighali N, Haghdoost F. Kohandel Gargari O, et al. JAMA Netw Open. 2024 Oct 1;7(10):e2438666. doi: 10.1001/jamanetworkopen.2024.38666. JAMA Netw Open. 2024. PMID: 39388181 Free PMC article.
See all "Cited by" articles

References

    1. Hershey AD, Kabbouche MA, O'Brien HL. Migraine. In: Kliegman RM, Stanton BF, Schor NF, St Geme JW, Behrman RE, editors. Nelson Textbook of Pediatrics. 20 th edition. Philadelphia: Saunders ; 2016. pp. 2866–73.
    1. Kacperski J, Hershey AD. Newly Approved Agents for the Treatment and Prevention of Pediatric Migraine. CNS Drugs. 2016;30(9):837–44. - PubMed
    1. 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. - PMC - PubMed
    1. Ashrafi MR, Najafi Z, Shafiei M, Heidari K, Togha M. Cinnarizine versus Topiramate in Prophylaxis of Migraines among Children and Adolescents: A Randomized, Double-Blind Clinical Trial. Iran J Child Neurol. 2014;8(4):18–27. - PMC - PubMed
    1. Fallah R, Akhavan Karbasi S, Shajari A, Fromandi M. The efficacy and safety of topiramate for prophylaxis of migraine in children. Iran J Child Neurol. 2013;7(4):7–11. - PMC - PubMed

LinkOut - more resources