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A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis.
Am J Obstet Gynecol. 2014 Nov; 211(5):479.e1-479.e13.AJ

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.

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.

Authors+Show Affiliations

Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH. Electronic address: ant@osumc.edu.Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.Sexual Health Clinic, Columbus Public Health, Columbus, OH.Sexual Health Clinic, Columbus Public Health, Columbus, OH.Sexual Health Clinic, Columbus Public Health, Columbus, OH.Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.Department of Obstetrics, Gynecology, and Reproductive Biology, Laboratory of Genital Tract Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.Sexual Health Clinic, Columbus Public Health, Columbus, OH.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.Division of Endocrinology, Diabetes, and Metabolism, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24949544

Citation

Turner, Abigail Norris, et al. "A Blinded, Randomized Controlled Trial of High-dose Vitamin D Supplementation to Reduce Recurrence of Bacterial Vaginosis." American Journal of Obstetrics and Gynecology, vol. 211, no. 5, 2014, pp. 479.e1-479.e13.
Turner AN, Carr Reese P, Fields KS, et al. A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis. Am J Obstet Gynecol. 2014;211(5):479.e1-479.e13.
Turner, A. N., Carr Reese, P., Fields, K. S., Anderson, J., Ervin, M., Davis, J. A., Fichorova, R. N., Roberts, M. W., Klebanoff, M. A., & Jackson, R. D. (2014). A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis. American Journal of Obstetrics and Gynecology, 211(5), e1-e13. https://doi.org/10.1016/j.ajog.2014.06.023
Turner AN, et al. A Blinded, Randomized Controlled Trial of High-dose Vitamin D Supplementation to Reduce Recurrence of Bacterial Vaginosis. Am J Obstet Gynecol. 2014;211(5):479.e1-479.e13. PubMed PMID: 24949544.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis. AU - Turner,Abigail Norris, AU - Carr Reese,Patricia, AU - Fields,Karen S, AU - Anderson,Julie, AU - Ervin,Melissa, AU - Davis,John A, AU - Fichorova,Raina N, AU - Roberts,Mysheika Williams, AU - Klebanoff,Mark A, AU - Jackson,Rebecca D, Y1 - 2014/06/17/ PY - 2014/04/02/received PY - 2014/05/24/revised PY - 2014/06/11/accepted PY - 2014/6/21/entrez PY - 2014/6/21/pubmed PY - 2015/3/7/medline KW - bacterial vaginosis KW - randomized controlled trial KW - sexually transmitted disease clinic KW - vitamin D SP - 479.e1 EP - 479.e13 JF - American journal of obstetrics and gynecology JO - Am. J. Obstet. Gynecol. VL - 211 IS - 5 N2 - 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. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/24949544/A_blinded_randomized_controlled_trial_of_high_dose_vitamin_D_supplementation_to_reduce_recurrence_of_bacterial_vaginosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(14)00592-4 DB - PRIME DP - Unbound Medicine ER -