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STD not decreased by metronidazole plus increasing the vitamin D levels to 30 ng – June 2014

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

American Journal of Obstetrics and Gynecology, DOI: 10.1016/j.ajog.2014.06.023
Abigail Norris Turner, PhD1, Corresponding author contact information, E-mail the corresponding author, Ms. Patricia Carr Reese, MPH1, Ms. Karen S. Fields, RN2, Ms. Julie Anderson, MPH2, Ms. Melissa Ervin, MT (ASCP)2, John A. Davis, MD, PhD1, Raina N. Fichorova, PhD, MD3, Mysheika Williams Roberts, MD, MPH2, Mark A. Klebanoff, MD, MPH4, 5, Rebecca D. Jackson, MD6

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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 STD clinic (clinicaltrials.gov registration NCT01450462).
All participants received 500mg oral metronidazole twice daily for seven days.
Intervention participants (n=59) also received nine doses of 50,000 international units 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.

Participants were primarily African-American (74%), with a median age of 26 years. Median pre-supplementation serum vitamin 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 recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio: 1.11 (95% confidence interval: 0.68, 1.81). By the 24-week visit, 65% of women randomized to vitamin D had BV, compared to 48% of control women. Median time to BV 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 STD clinic population.

VitaminDWiki suspect the lack of benefit was from

  1. May be difficult to impove immune system after metronidazole - wish they has a trial arm without metronidazole
  2. Average vitamin D levels only got to 31 ng after 9 weeks
    So at even at 9 weeks half of the women had less than 31 ng
    A loading dose of vitamin D probably would have been much better.

See also VitaminDWiki