BackgroundDespite the reduction in glycemic derangement in patients with type 1 diabetes mellitus (T1D) through dietary and therapeutic adjustments implemented before, during and after continuous exercise, evidence for its effectiveness with intermittent forms of exercise, such as soccer, is still lacking.Methods/designWe designed a study protocol for a randomized, crossover, double-blinded, controlled trial, for the evaluation of the effect that a strategy of dietary and therapeutic modifications may have on safety and performance of persons with T1D in soccer training sessions and cognitive testing. Inclusion criteria comprise: age older than 18 years, more than 2 years since T1D diagnosis, low C-peptide level, a stable insulin regimen, HbA1c less than 9.0% and regular participation in soccer activities. Our primary outcome evaluates safety regarding hypoglycemia events in patients using dietary and therapeutic adjustments, compared with the performance under the implementation of current American Diabetes Association (ADA) usual recommendations for nutritional and pharmacological adjustments for exercise. Additionally, we will evaluate as secondary outcomes: soccer performance, indexed by performance in well-established soccer skill tests, cognitive functions (indexed by Stroop, digital vigilance test (DVT), Corsi block-tapping task (CBP), and rapid visual information processing (RVIP) tests), and glycemic control measured with a continuous glucose monitor (CGM).DiscussionDietary and insulin adjustments standardized under a 4-step method strategy have never been tested in a clinical trial setting with intermittent forms of exercise, such as soccer. We hypothesize that through this strategy we will observe better performance by persons with T1D in soccer and cognitive evaluations, and more stable control of glycemic parameters before, during and after exercise execution, indexed by CGM measurements.Trial registrationISRCTN, ISRCTN17447843. Registered on 5 January 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2078-1) contains supplementary material, which is available to authorized users.

Background and Aim: The role of vitamin D plus calcium to protect against hip fracture in postmenopausal women remains controversial. Two major studies on this subject presented diverse outcomes; they implemented different doses of Vitamin D and Calcium, and they studied different populations. One study found evidence that Calcium plus Vitamin D do protect against fractures; the second study failed to demonstrate such protection. The aim of the present study is to test the hypothesis that a higher dose of vitamin D plus calcium is effective in reducing hip fractures in non-osteoporotic elderly women when compared to placebo. Methods: This will be a randomized, double-blinded superiority, multicenter trial involving three centers in São Paulo, Lima and Mexico City. After a three-month run-in period, 7176 participants will receive Calcium + Vitamin D or Placebo. The primary outcome is the occurrence of hip fractures assessed by the pelvic radiographic image; secondary outcomes include other fractures, the variation of Bone Mass Density, and the adverse effects rate. Conclusion: There is an increase in morbidity, mortality, and costs resulting from hip fractures since it is an important risk fact following accidents. A possible lack of benefit inside the active group drives more attention to an eventual over-prescription of those substances. Therefore, further studies including a phase II trial with different exclusion criteria could be desirable to confirm these findings and help to reduce the incidence of hip fractures..

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