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O06.2 A Pilot Randomised Controlled Trial of High-Dose Vitamin D Supplementation to Prevent Recurrence of Bacterial Vaginosis
  1. A Norris Turner1,
  2. P Carr Reese1,
  3. J Anderson1,
  4. K S Fields2,
  5. M Ervin2,
  6. M Klebanoff3,
  7. R Jackson4
  1. 1Division of Infectious Diseases, Ohio State University, Columbus, OH, United States
  2. 2Sexual Health Clinic, Columbus Public Health, Columbus, OH, United States
  3. 3The Research Institute, Nationwide Children’s Hospital, Columbus, OH, United States
  4. 4Division of Endocrinology, Diabetes and Metabolism, Ohio State University, Columbus, OH, United States


Background Bacterial vaginosis (BV) is the most common cause of vaginal infection worldwide and is associated with myriad negative reproductive health outcomes. Several cross-sectional studies indicate that women with low vitamin D levels have increased BV prevalence.

Methods This randomised, double-blinded, placebo-controlled trial started enrollment in September 2011 and concluded follow-up in January 2013. Women (n = 126) with symptomatic BV were enrolled from an urban STD clinic in the midwestern United States. All participants received standard metronidazole therapy. Intervention participants (n = 63) also received nine doses of 50,000 international units of cholecalciferol (vitamin D3) over 6 months; control arm women (n = 63) received matching placebo. BV status was assessed via Nugent scoring at three follow-up visits over six months. The primary analysis will be intention-to-treat using extended Cox proportional hazard models.

Results Participants’ median age was 26. Three-quarters (75%) of women were black and 25% were white. All reported a lifetime history of sex with men, and 29% also had a lifetime history of sex with women. At baseline, median serum vitamin D levels (measured as 25 -hydroxy vitamin D) were the same for intervention and control women at 15.85 ng/mL (interquartile range (IQR): 12.1–21.4 ng/mL); levels < 20 ng/mL are considered insufficient. Eight-one percent of participants returned for one or more follow-up visits. At trial completion, median vitamin D level among intervention women was 30.5 ng/mL (IQR 24.4–37.7 ng/mL), vs. 17.8 ng/mL among control women (IQR: 11.7–27.1 ng/mL). Nugent scoring is ongoing with primary results available in early spring 2013.

Conclusion Immunologic mechanisms regulated by vitamin D may play a role in BV recurrence, but no previous study has examined whether supplementing women with vitamin D will impact subsequent development of BV. If effective against BV, vitamin D supplementation can have worldwide impact as a safe, simple intervention.

  • bacterial vaginosis
  • STD clinic patients
  • Vitamin D

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