Luis Iván Lozano-Plata1, David Vega-Morales2, Jorge Antonio Esquivel-Valerio1, Mario Alberto Garza-Elizondo1, Dionicio A Galarza-Delgado1, Karina Silva-Luna1, Griselda Serna-Peña1, Janeth Sifuentes-Ramírez3, Alfredo de Jesús Garza-Guerra4, Raúl Díaz-Niño de Rivera4. 1. Universidad Autónoma de Nuevo León, Rheumatology Service, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León, Ave. Gonzalitos 235 Norte, Colonia Mitras Centro, Monterrey, Nuevo León, 64020, México. 2. Universidad Autónoma de Nuevo León, Rheumatology Service, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León, Ave. Gonzalitos 235 Norte, Colonia Mitras Centro, Monterrey, Nuevo León, 64020, México. drdavidvega@yahoo.com.mx. 3. School of Public Health and Nutrition, Universidad Autónoma de Nuevo León, Ave. Dr. Eduardo Aguirre Pequeño 905, Colonia Mitras Centro, Monterrey, N.L, 64460, México. 4. Universidad Autónoma de Nuevo León, Psychiatry Department, Hospital Universitario "Dr. José Eleuterio González", Universidad Autónoma de Nuevo León, Ave. Francisco I. Madero Pte. y Ave. Gonzalitos s/n, Colonia Mitras Centro, Monterrey, Nuevo León, 64460, México.
Abstract
INTRODUCTION:FM is a chronic musculoskeletal disorder characterized by the presence of generalized pain. There are contradictory results regarding the prevalence and supplementation effect of vitamin D deficiency on FM patients. We aim to determine the safety and efficacy of a 12-week vitamin D supplementation on FM patients. METHODS: We conducted a randomized, placebo-controlled, double-blind clinical trial. We included female participants of 18 years old or older, who met 1990 or 2010 ACR criteria for fibromyalgia. The Spanish validated FIQ and the VAS of pain were applied at baseline. The participants were then randomized to receive placebo or 50,000 IU of Vitamin D3 PO, weekly for 12 weeks. RESULTS: We included 80 patients. There was no statistical difference in the initial and final FIQ between both groups. The FIQ delta also did not prove to be different at the end of the study. The increase in vitamin D levels in the intervention group was corroborated. Regarding serious adverse effects, none was reported in both groups. There was no statistical difference in minor adverse events. CONCLUSION: In this double-blind placebo-controlled randomized study conducted to measure the efficacy and safety of vitamin D exclusively in patients with FM, we found that there is no evidence of a trend in favor of vitamin D treatment, since we did not observe improvement in the VAS of pain or FIQ. TRIAL REGISTRY: Clinical Trials.gov number: NCT03369379 Key Points • There are conflicting results in vitamin D to treat fibromyalgia. • In this double-blind, randomized controlled trial, we did not find a difference in the VAS nor FIQ with vitamin D supplementation. • The increase in vitamin D levels in the intervention group was corroborated.
RCT Entities:
INTRODUCTION: FM is a chronic musculoskeletal disorder characterized by the presence of generalized pain. There are contradictory results regarding the prevalence and supplementation effect of vitamin D deficiency on FM patients. We aim to determine the safety and efficacy of a 12-week vitamin D supplementation on FM patients. METHODS: We conducted a randomized, placebo-controlled, double-blind clinical trial. We included female participants of 18 years old or older, who met 1990 or 2010 ACR criteria for fibromyalgia. The Spanish validated FIQ and the VAS of pain were applied at baseline. The participants were then randomized to receive placebo or 50,000 IU of Vitamin D3 PO, weekly for 12 weeks. RESULTS: We included 80 patients. There was no statistical difference in the initial and final FIQ between both groups. The FIQ delta also did not prove to be different at the end of the study. The increase in vitamin D levels in the intervention group was corroborated. Regarding serious adverse effects, none was reported in both groups. There was no statistical difference in minor adverse events. CONCLUSION: In this double-blind placebo-controlled randomized study conducted to measure the efficacy and safety of vitamin D exclusively in patients with FM, we found that there is no evidence of a trend in favor of vitamin D treatment, since we did not observe improvement in the VAS of pain or FIQ. TRIAL REGISTRY: Clinical Trials.gov number: NCT03369379 Key Points • There are conflicting results in vitamin D to treat fibromyalgia. • In this double-blind, randomized controlled trial, we did not find a difference in the VAS nor FIQ with vitamin D supplementation. • The increase in vitamin D levels in the intervention group was corroborated.
Authors: Claus P Schmitt; Jennifer Obry; Reinhard Feneberg; Johannes D Veldhuis; Otto Mehls; Eberhard Ritz; Franz Schaefer Journal: J Am Soc Nephrol Date: 2003-12 Impact factor: 10.121
Authors: Charles G Helmick; David T Felson; Reva C Lawrence; Sherine Gabriel; Rosemarie Hirsch; C Kent Kwoh; Matthew H Liang; Hilal Maradit Kremers; Maureen D Mayes; Peter A Merkel; Stanley R Pillemer; John D Reveille; John H Stone Journal: Arthritis Rheum Date: 2008-01
Authors: Omar A Amin; Saleh M Abouzeid; Siham A Ali; Bashir A Amin; Khaled A Alswat Journal: Neuropsychiatr Dis Treat Date: 2019-05-27 Impact factor: 2.570