title: A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH. Electronic address: ant@osumc.edu.
authors.forename: Abigail Norris
authors.initials: AN
authors.lastname: Turner
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.
authors.forename: Patricia
authors.initials: P
authors.lastname: Carr Reese
authors.affiliation: Sexual Health Clinic, Columbus Public Health, Columbus, OH.
authors.forename: Karen S
authors.initials: KS
authors.lastname: Fields
authors.affiliation: Sexual Health Clinic, Columbus Public Health, Columbus, OH.
authors.forename: Julie
authors.initials: J
authors.lastname: Anderson
authors.affiliation: Sexual Health Clinic, Columbus Public Health, Columbus, OH.
authors.forename: Melissa
authors.initials: M
authors.lastname: Ervin
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.
authors.forename: John A
authors.initials: JA
authors.lastname: Davis
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Biology, Laboratory of Genital Tract Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
authors.forename: Raina N
authors.initials: RN
authors.lastname: Fichorova
authors.affiliation: Sexual Health Clinic, Columbus Public Health, Columbus, OH.
authors.forename: Mysheika Williams
authors.initials: MW
authors.lastname: Roberts
authors.affiliation: Departments of Pediatrics and Obstetrics and Gynecology, College of Medicine, the Ohio State University, Columbus, OH; Research Institute at Nationwide Children's Hospital, Columbus, OH.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Klebanoff
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.
authors.forename: Rebecca D
authors.initials: RD
authors.lastname: Jackson
mesh_terms: D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use; D002762:Cholecalciferol / Q000627:therapeutic use*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008795:Metronidazole / Q000627:therapeutic use; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D016585:Vaginosis, Bacterial / Q000188:drug therapy / Q000517:prevention & control*; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014815:Vitamins / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D014815:Vitamins; D014807:Vitamin D; D008795:Metronidazole; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D
keywords: bacterial vaginosis; randomized controlled trial; sexually transmitted disease clinic; vitamin D