Evidence map›Paper›PMID 24949544›Full record

Trial reportAmerican journal of obstetrics and gynecology2014

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

Abigail Norris Turner, Patricia Carr Reese, Karen S Fields, Julie Anderson, Melissa Ervin, John A Davis, Raina N Fichorova, Mysheika Williams Roberts, Mark A Klebanoff, Rebecca D Jackson

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01450462 (Vitamin D and Sexual Health), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01450462 nacompletednot on this map

Vitamin D and Sexual Health (the DASH Study)

TypeinterventionalSponsorOhio State UniversityRan2011 to 2013Enrolled118ConditionsBacterial VaginosisArmsVitamin D3 (cholecalciferol), Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  2. Relationship between vitamin D status and the vaginal microbiome during pregnancy.Journal of perinatology : official journal of the California Perinatal Association · 2019
    Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Abigail Norris TurnerDivision of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH. Electronic address: ant@osumc.edu.
Patricia Carr ReeseDivision of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.
Karen S FieldsSexual Health Clinic, Columbus Public Health, Columbus, OH.
Julie AndersonSexual Health Clinic, Columbus Public Health, Columbus, OH.
Melissa ErvinSexual Health Clinic, Columbus Public Health, Columbus, OH.
John A DavisDivision of Infectious Diseases, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.
Raina N FichorovaDepartment of Obstetrics, Gynecology, and Reproductive Biology, Laboratory of Genital Tract Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Mysheika Williams RobertsSexual Health Clinic, Columbus Public Health, Columbus, OH.
Mark A KlebanoffDepartments of Pediatrics and Obstetrics and Gynecology, College of Medicine, the Ohio State University, Columbus, OH; Research Institute at Nationwide Children's Hospital, Columbus, OH.
Rebecca D JacksonDivision of Endocrinology, Diabetes, and Metabolism, Department of Internal Medicine, College of Medicine, the Ohio State University, Columbus, OH.

Funding

The Ohio State University Center for clinical and Translational ScienceUL1TR001070 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2013 to 2017
$22.6M
The Ohio State University Center for Clinical and Translational Science (UL1)UL1TR000090 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2012 to 2013
$7.9M
The Ohio State University Center for Clinical and Translational Science (KL2)KL2RR025754 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$3.5M
Vitamin D and the prevalence, incidence, and persistence of bacterial vaginosisR21AI095987 · NIAID · OHIO STATE UNIVERSITY · PI NORRIS TURNER, ABIGAIL · 2011 to 2012
$443k
NCATS NIH HHS 8UL1TR000090-05NCATS NIH HHS UL1 TR000090NCATS NIH HHS UL1 TR001070NCRR NIH HHS KL2 RR025754NCRR NIH HHS KL2RR025754NIAID NIH HHS R21 AI095987
6 · The paper itself

Abstract

objectiveLow 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

designThis 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.

resultsMost 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.

conclusionWomen 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.

Indexed as

AdultAnti-Infective AgentsCholecalciferolDietary SupplementsDouble-Blind MethodFemaleHumansMetronidazoleRecurrenceTime FactorsTreatment OutcomeVaginosis, BacterialVitamin DVitaminsYoung Adult25-hydroxyvitamin DAnti-Infective AgentsCholecalciferolMetronidazoleVitamin DVitaminsbacterial vaginosisrandomized controlled trialsexually transmitted disease clinicvitamin D

Identifiers

PMID24949544
PMCPMC4254061

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.