Vaginosis not reduced by average of 2800 IU vitamin D daily – RCT

Created October 2014

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

American Journal of Obstetrics & Gynecology, Volume 211, Issue 5, Pages 479.e1–479.e13, November 2014

Presented at the joint meeting of the International Society for Sexually Transmitted Disease Research and the International Union against Sexually Transmitted Infections, Vienna, Austria, July 13-17, 2013.

Abigail Norris Turner, PhDemail, Patricia Carr Reese, MPH, Karen S. Fields, RN, Julie Anderson, MPH, Melissa Ervin, MT(ASCP), John A. Davis, MD, PhD, Raina N. Fichorova, MD, PhD, Mysheika Williams Roberts, MD, MPH, Mark A. Klebanoff, MD, MPH, Rebecca D. Jackson, MD

Received: April 2, 2014; Received in revised form: May 24, 2014; Accepted: June 11, 2014; Published Online: June 17, 2014

DOI: http://dx.doi.org/10.1016/j.ajog.2014.06.023

Several previous studies found that higher level of vitamin D is needed For example: 6,000 IU per day has been successful with white women This study used an average of 2800 IU ( 50,000 IU/ 18 days) And, 74% of the participants were Black – so probably would need > 6,000 IU Suspect that researchers would find benefit for women achieving > 40ng/ml level of vitamin D 📄 Download the PDF from VitaminDWiki. 1. See also VitaminDWiki * Overview Women and Vitamin D * Vaginal Vitamin D reduced vaginal infections - Jan 2014 * Vaginal suppository of 6300 IU vitamin D stopped vaginal infection – Feb 2011 previous report by Jan 2014 authors * ALL of the top 10 health problems of women are associated with low vitamin D

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.

Tags: Women