Turner Abigail Norris, Carr Reese Patricia, Fields Karen S, Anderson Julie, Ervin Melissa, Davis John A, Fichorova Raina N, Roberts Mysheika Williams, Klebanoff Mark A, Jackson Rebecca D
Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.
Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.
Am J Obstet Gynecol. 2014 Nov;211(5):479.e1-479.e13. doi: 10.1016/j.ajog.2014.06.023. Epub 2014 Jun 17.
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.
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.
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.
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.
血清维生素D水平低与生殖道疾病细菌性阴道病（BV）患病率增加有关。本试验的目的是评估高剂量补充维生素D对BV复发的影响。
这项随机、安慰剂对照、双盲试验纳入了118名来自城市性传播疾病诊所的有症状BV女性（clinicaltrials.gov注册号NCT01450462）。所有参与者每天口服两次500毫克甲硝唑，共7天。干预组参与者（n = 59）在24周内还接受了9剂50,000国际单位的胆钙化醇（维生素D3）；对照组女性（n = 59）接受匹配的安慰剂。在4周、12周和24周后通过纽金特评分评估复发性BV。我们采用意向性分析方法评估干预效果，拟合Cox比例风险模型以评估随访期间的复发性BV。
大多数参与者（74%）为黑人，中位年龄为26岁。随机分组时，各分组的补充前血清25-羟基维生素D [25(OH)D]中位数相似：维生素D组为16.6纳克/毫升，对照组为15.8纳克/毫升。试验结束时，接受维生素D的女性中25(OH)D中位数为30.5纳克/毫升，而对照组女性为17.8纳克/毫升；接受维生素D的女性中有16%，接受安慰剂的女性中有57%仍存在维生素D缺乏（<20纳克/毫升）。在4周和12周随访时，随机分配到维生素D组的女性中BV患病率与随机分配到安慰剂组的女性非常相似，但到24周随访时，维生素D组女性中BV患病率为65%，对照组女性中为48%。补充维生素D并未降低BV复发率（意向性分析风险比为1.11；95%置信区间为0.68 - 1.81）。在经历复发性BV的女性中，维生素D组复发的中位时间为13.7周，对照组为14.3周。
接受维生素D的女性血清25(OH)D显著升高，但在这个高危性传播疾病诊所人群中，这种升高与BV复发率降低无关。
