Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Buettner C
PROVIDER: S-EPMC4715556 | biostudies-literature | 2015 Dec
REPOSITORIES: biostudies-literature
Publications
Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial.
Buettner Catherine C Nir Rony-Reuven RR Bertisch Suzanne M SM Bernstein Carolyn C Schain Aaron A Mittleman Murray A MA Burstein Rami R
Annals of neurology 20151113 6
<h4>Objective</h4>The aim of this work was to assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine.<h4>Methods</h4>We performed a randomized, double-blind, placebo-controlled trial with a 12-week baseline period and 24-week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice-daily plus vitamin D3 1,000 international units capsules twice-daily or matching ...[more]
Similar Datasets
Project description:BackgroundVitamin D insufficiency is associated with risks of cardiovascular diseases (CVD) and cancer in observational studies, but evidence for benefits with vitamin D supplementation is limited.ObjectivesTo investigate the effects of vitamin D3 supplementation on CVD and cancer incidences.MethodsThe study was a 5-year, randomized, placebo-controlled trial among 2495 male participants ≥60 years and post-menopausal female participants ≥65 years from a general Finnish population who were free of prior CVD or cancer. The study had 3 arms: placebo, 1600 IU/day, or 3200 IU/day vitamin D3. Follow-up was by annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person investigations. The primary endpoints were incident major CVD and invasive cancer. Secondary endpoints included the individual components of the primary CVD endpoint (myocardial infarction, stroke, and CVD mortality), site-specific cancers, and cancer death.ResultsDuring the follow-up, there were 41 (4.9%), 42 (5.0%), and 36 (4.3%) major CVD events in the placebo, 1600 IU/d (compared with placebo: HR: 0.97; 95% CI: 0.63-1.49; P = 0.89), and 3200 IU/d (HR: 0.84; 95% CI: 0.54-1.31; P = 0.44) arms, respectively. Invasive cancer was diagnosed in 41 (4.9%), 48 (5.8%), and 40 (4.8%) participants in the placebo, 1600 IU/d (HR: 1.14; 95% CI: 0.75-1.72; P = 0.55), and 3200 IU/d (HR: 0.95; 95% CI: 0.61-1.47; P = 0.81) arms, respectively. There were no significant differences in the secondary endpoints or total mortality. In the subcohort, the mean baseline serum 25-hydroxyvitamin D concentration was 75 nmol/L (SD, 18 nmol/L). After 12 months, the concentrations were 73 nmol/L (SD, 18 nmol/L), 100 nmol/L (SD, 21 nmol/L), and 120 nmol/L (SD, 22 nmol/L) in the placebo, 1600 IU/d, and 3200 IU/d arms, respectively.ConclusionsVitamin D3 supplementation did not lower the incidences of major CVD events or invasive cancer among older adults, possibly due to sufficient vitamin D status in most participants at baseline.
| S-EPMC9071497 | biostudies-literature
Project description:Background: One in every four patients with a first episode of non-gallstone-related acute pancreatitis (AP) develops recurrent disease. Recurrent episodes of AP or acute flares of chronic pancreatitis (CP) are associated with decreased quality of life and progression of the disease. Besides removing the etiology of pancreatitis (which sometimes is not possible), there are no effective measures to prevent recurrence. Meta-analyses of randomized controlled trials, as well as epidemiological and cohort studies, suggest that statins may be protective against the development of index AP. Methods: The SIMBA study is a triple-blind randomized placebo-controlled, parallel-group multicenter trial. Patients with recurrent AP or with acute flares of CP (at least two episodes in the last 12 months) will be randomized to receive simvastatin 40 mg daily or placebo. During a 3-year study period, 144 patients (72 per arm of treatment) from 26 centers will be enrolled. The patients will receive the study treatment for 1 year. The primary aim is to compare the recurrence of AP or acute flares in CP. Secondary endpoints include the incidence of new-onset diabetes mellitus, new-onset exocrine pancreatic insufficiency (EPI), new-onset imaging signs of CP, frequency of all-cause hospital admissions, severity of AP, adherence to treatment, and frequency of adverse events. Discussion: The SIMBA trial will ascertain whether simvastatin, a safe, widely used and inexpensive drug, can change the natural course of recurrent pancreatitis. Trial Registration: ClinicalTrials.gov Identifier: NCT04021498.
| S-EPMC7902790 | biostudies-literature
Project description:Use of auriculotherapy to prevent episodic migraine pain has seldom been reported. The aim of this open study was to show that three sessions of auriculotherapy, 1 month apart, using semi-permanent needles decrease frequency and intensity of an attack in patients presenting episodic migraine. A total of 90 patients were randomized to the treatment group (AUR group, n = 58) or the control group (C group, n = 32). Four patients dropped out during the study (three in the AUR group and one in the C group). The number of days with migraine and non-migraine headache was similar when the analysis focused on the 3 months of the study or on the difference in each group of this number between the 3 months preceding the inclusion and the 3 months of the study (p = 0.123). AUR group patients had fewer days with non-migraine headache (p = 0.011) and took less Triptans (p = 0.045) than group C. Number of days with migraine, sum of the pain intensities of all migraines and non-migraine headaches, and total number of analgesics taken, other than triptan, were similar between groups. MIDAS score decreased with time in the AUR group while it increased in the C group whether in absolute values (p = 0.035) or as categories (p = 0.037). These contrasted results should lead to further study of the effectiveness of auriculotherapy for the prevention of migraine. Clinical trail registration: Protocol registered on the Clinicaltrials.gov, website (January 30, 2017, NCT03036761).
| S-EPMC10241207 | biostudies-literature
Project description:BackgroundAcupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture.MethodsWe performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5-8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life.ResultsCompared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5-8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13-16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference -1.06 [95% confidence interval (CI) -1.77 to -0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference -1.22 [95% CI -1.92 to -0.52], p < 0.001; Yangming-specific acupuncture v. control: difference -0.91 [95% CI -1.61 to -0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups.InterpretationAcupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture.Trial registrationClinicaltrials.gov NCT00599586.
| S-EPMC3291669 | biostudies-literature
Project description:Objective: Assessing the effects of caffeine withdrawal on migraine. Background: The effects of caffeine withdrawal on migraineurs are at large unknown. Methods: This was a randomized, double-blind, crossover study (NCT03022838), designed to enroll 80 adults with episodic migraine and a daily consumption of 300-800 mg caffeine. Participants substituted their estimated dietary caffeine with either placebo capsules or capsulated caffeine tablets for 5 weeks before switching the comparators for 5 more weeks. Results: The study was terminated due to low recruitment. Ten subjects with a mean age of 46.3 ± 9.9 years, BMI of 24.9 ± 3.7, and a mean blood pressure of 134/83 ± 17/12 mmHg were enrolled. The average consumption of caffeine per day was 539 ± 196.3 mg. The average monthly headache days and migraine attack frequency at baseline was 11.5 ± 4.9 and 5.2 ± 1.2, respectively. At baseline Pittsburgh Sleep Quality Index was 5.8 ± 2.5 and HIT-6 was 62.8 ± 3.9. There were no differences in these or in parameters from actigraphy during the caffeine period compared with the placebo period. One subject withdrew just after entering the study. In the remaining nine, withdrawal triggered severe migraine attacks in seven, causing one more drop-out, and a typical caffeine withdrawal syndrome in two. Caffeine continuation did not trigger migraines, but one attack occurred in the wake of caffeine reintroduction. Conclusions: The study failed to answer how caffeine withdrawal affects migraineurs over time, but showed that abrupt withdrawal of caffeine is a potent trigger for migraine attacks.
| S-EPMC7512113 | biostudies-literature
Project description:We undertook a 2X2 factorial, randomized controlled trial (RCT) to assess whether vitamin D3 supplementation (10,000 international units per week) versus placebo and gargling versus no gargling could prevent viral, clinical upper respiratory tract infection (URTI) in university students.We randomized 600 students into 4 treatment arms: 1) vitamin D3 and gargling, 2) placebo and gargling, 3) vitamin D3 and no gargling, and 4) placebo and no gargling. Students completed weekly electronic surveys and submitted self-collected mid-turbinate nasal flocked swabs during September and October in 2010 or 2011. Symptomatic students also completed an electronic symptom diary. The primary and secondary outcomes were the occurrence of symptomatic clinical URTI and laboratory confirmed URTI respectively.Of 600 participants, 471 (78.5%) completed all surveys while 43 (7.2%) completed none; 150 (25.0%) reported clinical URTI. Seventy participants (23.3%) randomized to vitamin D3 reported clinical URTI compared to 80 (26.7%) randomized to placebo (RR:0.79, CI95:0.61-1.03, p?=?0.09). Eighty-five participants (28.3%) randomized to gargling reported clinical URTI compared to 65 participants (21.7%) randomized to the no gargling arm (RR:1.3, CI95:0.92-1.57, p?=?0.19). Laboratory testing identified 70 infections (46.7 per 100 URTIs). Vitamin D3 treatment was associated with a significantly lower risk for laboratory confirmed URTI (RR: 0.54, CI95:0.34-0.84, p?=?0.007) and with a significantly lower mean viral load measured as log10 viral copies/mL (mean difference: -0.89, CI95: -1.7, -0.06, p?=?0.04). Fewer students assigned to gargling experienced laboratory confirmed URTI, however this was not statistically significant (RR:0.82, CI95:0.53-1.26, p?=?0.36).These results suggest that vitamin D3 is a promising intervention for the prevention of URTI. Vitamin D3 significantly reduced the risk of laboratory confirmed URTI and may reduce the risk of clinical infections.NCT01158560.
| S-EPMC4041358 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:Falls are the leading cause of unintentional injury and injury-related death among older people. In addition to physical activity, vitamin D also may affect balance and neuromuscular function. Low serum 25-hydroksivitamin D level increases the risk of bone loss, falls and fractures. Thus, an appropriate exercise program and sufficient vitamin D intake may significantly improve not only functional balance, but also balance confidence. Balance represents a complex motor skill determined by reaction time, muscle strength, and speed and coordination of movement.A 2-year randomized double-blind placebo-controlled vitamin D and open exercise trial of 409 home-dwelling women 70 to 80 years of age comprising four study arms: 1) exercise + vitamin D (800 IU/d), 2) exercise + placebo, 3) no exercise + vitamin D (800 IU/d), 4) no exercise + placebo. In addition to monthly fall diaries, general health status, life style, bone health, physical functioning, and vitamin D metabolism will be assessed. The primary outcomes are the rate of falls and fall-related injuries. Secondary outcomes include changes in neuromuscular functioning (e.g. body balance, muscle strength), ADL- and mobility functions, bone density and structure, cardiovascular risk factors, quality of life and fear of falling.The successful completion of this trial will provide evidence on the effectiveness of exercise and vitamin D for falls reduction.ClinicalTrial.gov -register (NCT00986466).
| S-EPMC3342151 | biostudies-literature
Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.
| S-EPMC4815216 | biostudies-other
Project description:<p>The VISP trial (PI Jim Toole, M.D., Wake Forest University School of Medicine) was a multi-center, double-blind, randomized, controlled clinical trial that enrolled patients aged 35 or older with Hcy levels above the 25th percentile at screening and a non-disabling cerebral infarction (NDCI) within 120 days of randomization [Toole, 2002]. The trial was designed to determine if daily intake of a multivitamin tablet with high dose folic acid, vitamin B6 and vitamin B12 reduced recurrent cerebral infarction (primary endpoint), and nonfatal myocardial infarction (MI) or mortality (secondary endpoints). Subjects were randomly assigned to receive daily doses of the high-dose formulation (n=1,827), containing 25mg pyridoxine (B6), 0.4mg cobalamin (B12), and 2.5mg folic acid; or the low-dose formulation (n=1,853), containing 200µg pyridoxine, 6 µg cobalamin and 20µg folic acid. Enrollment in VISP began in August 1997, and was completed in December 2001, with 3,680 participants enrolled.</p> <p>Within the trial, 2,164 participants from 46 clinic sites provided DNA and agreed for it to be shared for use in a genetic subset study of VISP. This study is part of the Genomics and Randomized Trials Network (GARNET, <a href="http://www.garnetstudy.org" target="_blank">http://www.garnetstudy.org</a>) funded by the National Human Genome Research Institute (NHGRI). The overarching goal is to identify novel genetic factors that contribute to stroke through large-scale genome-wide association studies of treatment response in randomized clinical trials. Genotyping was performed at the Johns Hopkins University Center for Inherited Disease Research (CIDR). Data cleaning and harmonization were performed at the GARNET Coordinating Center at the University of Washington.</p> <p>The data of the VISP trial will be released to dbGaP users in several segments; the current segment, version 1 (phs000343.v1.p1), consists of n=4 phenotype datasets, and all raw, cleaned and imputed genotype data.</p> <p>Toole, J. F. (2002). Vitamin intervention for stroke prevention. J Neurol Sci, 203-204, 121-4. PMID: <a href="http://www.ncbi.nlm.nih.gov/pubmed/12417369" target="_blank">12417369</a>.</p>
| phs000343.v1.p1 | EGA