A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis.

OBJECTIVE: Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis (BV). The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence. STUDY DESIGN: This randomized, placebo-controlled, double-blinded trial enrolled 118 women with symptomatic BV from an urban sexually transmitted disease clinic (clinicaltrials.gov registration NCT01450462). All participants received 500 mg of oral metronidazole twice daily for 7 days. Intervention participants (n = 59) also received 9 doses of 50,000 IU of cholecalciferol (vitamin D3) over 24 weeks; control women (n = 59) received matching placebo. Recurrent BV was assessed via Nugent scoring after 4, 12, and 24 weeks. We assessed the effect of the intervention using an intention-to-treat approach, fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period. RESULTS: Most participants (74%) were black, with a median age of 26 years. Median presupplementation serum 25-hydroxyvitamin D [25(OH)D] was similar across randomization arms: 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm. At trial completion, median 25(OH)D among women receiving vitamin D was 30.5 ng/mL, vs 17.8 ng/mL in control women; 16% of women receiving vitamin D and 57% receiving placebo remained vitamin D deficient (<20 ng/mL). BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4- and 12-week visits, but by the 24-week visit, BV prevalence was 65% among women in the vitamin D arm and 48% among control women. BV recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio, 1.11; 95% confidence interval, 0.68-1.81). Among women experiencing recurrent BV, median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm. CONCLUSION: Women receiving vitamin D experienced significant increases in serum 25(OH)D, but this increase was not associated with decreased BV recurrence in this high-risk sexually transmitted disease clinic population.

Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation.

This paper describes the performance of a 16-channel implanted neuroprosthesis for standing and transfers after spinal cord injury including four-contact nerve-cuff electrodes stimulating the femoral nerve for knee extension. Responses of the nerve-cuffs were stable and standing times increased by 600% over time-matched values with a similar eight-channel neuroprosthesis utilizing muscle-based electrodes on vastus lateralis for knee extension.

Energy cost of the case Western reserve standing neuroprosthesis.

OBJECTIVE: To determine the oxygen consumption of a person with C7 American Spinal Injury Association (ASIA) grade B tetraplegia using the Case Western Reserve/Veterans Administration (CWRU/VA) standing neuroprosthesis. DESIGN: Measure the oxygen consumption and carbon dioxide production of a person with C7 ASIA grade B tetraplegia at rest, standing in the parallel bars with the CWRU/VA system on, ambulating in the parallel bars, and transferring from a wheelchair to a mat with the system on. SETTING: University medical center. PARTICIPANT: A 26-year-old man with C7 ASIA grade B tetraplegia. The subject was a recipient of the CWRU/VA standing neuroprosthesis. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Measurement of oxygen consumption and carbon dioxide production using a metabolic cart. RESULTS: Oxygen consumption of the subject was 1.22mL.kg(-1).min(-1) at rest. It was 4.7mL.kg(-1).min(-1) while standing in the parallel bars, 7.2mL.kg(-1).min(-1) while ambulating in the parallel bars, and 7.9mL.kg(-1).min(-1) when transferring from a wheelchair to a mat. CONCLUSIONS: Oxygen consumption of the subject when using the system is about 2 metabolic equivalent units, which is compatible with sustained use of the system for standing.

Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury.

This study describes the performance of surgically-implanted epimysial stimulating electrodes in the muscles of the lower extremities for use in functional neuromuscular stimulation (FNS) systems for standing after spinal cord injury. A total of 86 epimysial electrodes were implanted in 13 volunteers with low tetraplegia or paraplegia receiving the Case Western Reserve University/Veteran Affairs (CWRU/VA)-implanted standing/transfer neuroprosthesis. The neuroprosthesis consisted of bilateral epimysial electrodes in the knee and hip extensors (vastus lateralis, gluteus maximus, and adductor magnus or semimembranosus) and intramuscular electrodes at the T12/L1 or L1/L2 spinal roots for trunk extension. Recruitment properties, stimulated knee and hip extension moments, standing performance, and mechanical integrity over time were measured for a period up to four years post-implantation. Stimulated thresholds were stable and recruitment was sufficient to generate joint moments adequate for standing, with up to 97% body weight supported by the legs. Four mechanical failures were observed, all in the posterior muscles of the thigh, leaving 95% of all electrodes operational at all followup intervals. Probability of 24-month survival is estimated to be 93% plateauing to a steady state of 90% at four years. These results indicate that epimysial designs are appropriate for long-term clinical use in the large muscles of the lower extremities with implanted motor system neuroprostheses.

Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury.

This study was completed to understand the usage patterns, system performance, degree of satisfaction, complications, and health benefits as perceived by recipients of a surgically implanted neuroprosthesis for exercise, standing, and transfers in individuals with low-cervical or thoracic spinal cord injury (SCI). A standardized telephone survey was administered to 11 recipients of the Case Western Reserve University/Veterans Affairs (CWRU/VA) implanted standing neuroprosthesis with more than 12 months of experience with the functional electrical stimulation (FES) system. Nine implant recipients were using the neuroprosthesis regularly for standing and/or exercising at the time of the survey. All 11 implant recipients noted improved health and a reduced incidence of pressure sores, leg spasms, and urinary tract infections (UTIs). No incidents of deep-vein thrombosis, infection, cellulitis, or electrical burns because of the neuroprosthesis were noted. System recipients uniformly felt that the neuroprosthesis resulted in better overall health and general well-being. Subjects were moderately to very satisfied with the performance of the neuroprosthesis and unanimously expressed a willingness to repeat the surgery and rehabilitation to obtain the same clinical outcome. All implant recipients reported the system to be safe, reliable, and easy to use. The implanted standing neuroprosthesis appears to be a clinically acceptable and effective means of providing the ability to exercise, stand, and transfer to selected individuals with paraplegia or low tetraplegia.