Bacterial VaginosisDASHNCT01450462
Vitamin D and Sexual Health
A study testing Vitamin D3 (cholecalciferol) in people with Bacterial Vaginosis, run by Ohio State University at 1 site in United States.
Trial summary
Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Vitamin D3 (cholecalciferol)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- speak English;
- be between 18 and 50 years old, inclusive;
- be pre-menopausal;
- have at least one ovary;
- be positive for bacterial vaginosis
Who cannot join
- pregnant at enrollment or in the previous 3 months;
- planning to become pregnant in the next six months;
- currently breastfeeding;
- currently be menstruating heavily;
- have a contraindication to oral metronidazole treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbus Public Health Sexual Health Clinic
Columbus, Ohio, 43215
About this study
Official title: Vitamin D and Sexual Health (the DASH Study)
Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the United States (US): 23% of white women versus. 52% of black women have BV. The investigators hypothesize that inadequate vitamin D contributes to BV development and/or recurrence. Vitamin D is essential to immune function, serving both to stimulate mechanisms associated with pathogen elimination and to regulate immune response. According to nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two recent analyses, low vitamin D was associated with higher BV prevalence in pregnant African-Americans; a third replicated this finding in pregnant African-American and white women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a public sexually transmitted disease (STD) clinic. This small (n=150), two-arm, placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform the development of future large-scale RCT design and implementation.
- Conditions
- Bacterial Vaginosis
- Being tested
- Vitamin D3 (cholecalciferol), Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (cholecalciferol)Dietary supplement
Women in the vitamin D arm take 50,000 international units (IU) of vitamin D3 (cholecalciferol) weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments
PlaceboDietary supplement
Women in the placebo arm will take their matching supplement weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D (cholecalciferol) | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 (cholecalciferol) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vitamin D level
To assess the effect of vitamin D supplementation on serum vitamin D levels after 24 weeks
Measured: 24 weeks
Serum and cervical immunoinflammatory mediators
To assess the effect of vitamin D supplementation on levels of and correlations between BV-associated and vitamin D-associated immunoinflammatory mediators after 24 weeks
Measured: 24 weeks
Bacterial vaginosis recurrence
To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Norris Turner, Ohio State University
- Investigators
- Abigail Norris Turner, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450462
- Sponsor's protocol ID
- KL2RR025754-ANT
- Other IDs
- KL2RR025754
- Acronym
- DASH
- Status last verified
- Dec 2013
- First submitted
- 7 Oct 2011
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turner AN, Carr Reese P, Fields KS, Anderson J, Ervin M, Davis JA, Fichorova RN, Roberts MW, Klebanoff MA, Jackson RD. 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. doi: 10.1016/j.ajog.2014.06.023. Epub 2014 Jun 17.
PubMed 24949544
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Sexual Health (the DASH Study)
- ClinicalTrials.gov ID
- NCT01450462
- Acronym / sponsor ID
- DASH / KL2RR025754-ANT
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the United States (US): 23% of white women versus. 52% of black women have BV. The investigators hypothesize that inadequate vitamin D contributes to BV development and/or recurrence. Vitamin D is essential to immune function, serving both to stimulate mechanisms associated with pathogen elimination and to regulate immune response. According to nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two recent analyses, low vitamin D was associated with higher BV prevalence in pregnant African-Americans; a third replicated this finding in pregnant African-American and white women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a public sexually transmitted disease (STD) clinic. This small (n=150), two-arm, placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform the development of future large-scale RCT design and implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D (cholecalciferol) | Experimental | Dietary Supplement: Vitamin D3 (cholecalciferol) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- speak English;
- be between 18 and 50 years old, inclusive;
- be pre-menopausal;
- have at least one ovary;
- be positive for bacterial vaginosis
Key exclusion criteria (5 listed)
- pregnant at enrollment or in the previous 3 months;
- planning to become pregnant in the next six months;
- currently breastfeeding;
- currently be menstruating heavily;
- have a contraindication to oral metronidazole treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (cholecalciferol)Women in the vitamin D arm take 50,000 international units (IU) of vitamin D3 (cholecalciferol) weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments | Dietary supplement | Vitamin D (cholecalciferol) |
| PlaceboWomen in the placebo arm will take their matching supplement weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments | Dietary supplement | Placebo |
Primary outcome
Serum vitamin D level
Time frame: 24 weeks
To assess the effect of vitamin D supplementation on serum vitamin D levels after 24 weeks
Serum and cervical immunoinflammatory mediators
Time frame: 24 weeks
To assess the effect of vitamin D supplementation on levels of and correlations between BV-associated and vitamin D-associated immunoinflammatory mediators after 24 weeks
Bacterial vaginosis recurrence
Time frame: 24 weeks
To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Derived from this study: PubMed 24949544Turner AN, Carr Reese P, Fields KS, Anderson J, Ervin M, Davis JA, Fichorova RN, Roberts MW, Klebanoff MA, Jackson RD. 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. doi: 10.1016/j.ajog.2014.06.023. Epub 2014 Jun 17.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Norris Turner, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (cholecalciferol) in people with Bacterial Vaginosis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum vitamin D level (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.