Vitamin D DeficiencyPhase 1NCT02186535
The Role of Vitamin D in Female Reproductive Tract Immunity
A Phase 1 study testing Vitamin D and Calcium in people with Vitamin D Deficiency, run by CONRAD at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of approximately 8 weeks of Vitamin D (VitD) and calcium supplementation, using daily versus weekly supplementation regimens, on female reproductive tract immunity. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2015
- Phase
- Phase 1
- 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Serum 25(OH)D ≤ 25ng/mL (62 nmol/L)
- In good health, as evidenced by history and procedures at screening visits without any clinically significant systemic disease.
- Not at risk of an STI, meaning: In a monogamous heterosexual or same sex relationship with a partner who is not known to be HIV positive and has no known risks for STIs, or Sexually abstinent
- Willing and able to comply with study procedures
- 21 to 50 years of age
- Not at risk for pregnancy, meaning: Protected from pregnancy due to surgical sterilization of participant and or her sexual partner, Consistent condom use, In a same sex relationship or, Abstinent from sexual activity and planning to remain abstinent for the duration of the study
- Regular menstrual cycles (every 21 - 35 days) for the past two cycles, per participant report
- Willing to use sunscreen of SPF15 or higher when exposed to the sun for at least 15 minutes, and to avoid use of non-study Vitamin D, calcium, and multivitamin supplementation.
Who cannot join
- A clinically significant history of an abnormal Pap test (by written report) in the past year that has not been evaluated and/or treated, if indicated, according to standard guidelines
- Surgery or biopsy of the vagina or cervix within 14 days
- Current STI or lower genital tract infection including HIV-1, Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Neisseria Gonorrhoeae (NG), Hepatitis B, yeast vaginitis or bacterial vaginosis (BV) (by Nugent score of 7 - 10); this does not include asymptomatic HSV or human papilloma virus (HPV)
- Current presence of vulvar, anal and/or vaginal genital warts
- Current tobacco use of any amount
- Body Mass Index (BMI) of ≥ 35 kg/m2
Show all 18Show fewer
- History of sensitivity/allergy to any component of the study product, topical anesthetic, or allergy to silver nitrate and/or Monsel's solution
- Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy, or taking anticoagulant drugs
- Grade 2 or higher laboratory abnormality, per the August 2009 update of the DAIDS Table for Grading the Severity of Adverse Events
- Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals, antivirals (e.g., acyclovir or valacyclovir) or antiretrovirals (e.g., Viread). Note: Participants should avoid NSAIDS except for treatment of dysmenorrhea during menses. Participants may use acetaminophen on an as-needed but not daily basis during the study.
- Known risk factors for hypercalcemia (e.g. malignancy or granulomatous disease) or malabsorption syndromes (e.g. celiac disease, radiation enteritis, active inflammatory bowel disease).
- Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise the ability to comply with study protocols, such as any major chronic illness including but not limited to cancer, serious autoimmune disease, metabolic disorders or a major psychiatric disorder (e.g., schizophrenia)
- Current participation in any other drug or device study, or any study which, in the opinion of the investigator, would jeopardize interpretation of results of this study
- Use of depot medroxyprogesterone acetate (DMPA) in last six months
- Use of any other hormonal contraceptive method (oral, transdermal, transvaginal, implant, or intrauterine device) without 2 subsequent, normal menses since stopping hormonal contraceptives
- Current use of copper IUD
- Currently pregnant or pregnancy within the past 3 months
- Currently breastfeeding or having breastfed an infant in the last two months
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School CONRAD Clinical Research Center
Norfolk, Virginia, 23507
About this study
The purpose of this study is to assess the impact of approximately 8 weeks of Vitamin D (VitD) and calcium supplementation, using daily versus weekly supplementation regimens, on female reproductive tract immunity.
Read the detailed description
This outpatient open label study will assess the impact of 8 weeks of daily versus weekly VitD and calcium supplementation on measures of cervicovaginal (CV) innate immune function, including antimicrobial and proinflammatory gene expression, Toll-like receptor (TLR)-mediated responses, immunohistochemical (IHC) analysis of immune cell markers, and microbiota in premenopausal women with insufficient serum VitD levels at baseline.
Women will be seen in 3 study visits and will be contacted by one scheduled follow-up telephone call after their final study visit. Volunteers will be consented at Visit 1 and undergo procedures to confirm they are eligible to continue in the study.
Once it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, baseline blood and genital samples will be taken in the luteal phase at Visit 2. The participant will then be given their first dose of VitD 4000 IU daily or 50,000 IU weekly in capsule form, which they will then administer for 8 weeks. Participants will also administer 1000 mg of calcium daily. Participants will return upon completion of supplementation for repeat of blood and genital samples (Visit 3).
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D and Calcium
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and CalciumDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Daily dosing | Other | Daily oral capsule of Vitamin D in 4000 IU/day with daily oral capsules of 1000mg of calcium Receives: Dietary Supplement: Vitamin D and Calcium |
| weekly dosing | Other | Oral capsule Vitamin D 50,000 IU/week with a oral capsule of 1000mg of calcium, daily Receives: Dietary Supplement: Vitamin D and Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D concentrations in serum and vaginal secretions
Assess the impact of daily versus weekly Vitamin D and calcium supplementation regimens on Vitamin D concentrations in serum and on soluble markers innate mucosal immunity and inflammatory response in cervicovaginal secretions.
Measured: over 8 weeks of use
Secondary outcomes (2)
Assessment of Gene Expression
Assess gene expression of epithelial factors associated with innate immune response in CV tissues before and after VitD and calcium supplementation.
Measured: over 8 weeks of use
Assessment of immune cell activation and phenotype by IHC in CV tissues
Assess immune cell activation and phenotype by IHC in CV tissues before and after VitD and calcium supplementation.
Measured: over 8 weeks of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Thurman, M.D., Principal investigator, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186535
- Sponsor's protocol ID
- A14-131
- Status last verified
- Jan 2016
- First submitted
- 1 Jul 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin D in Female Reproductive Tract Immunity
- ClinicalTrials.gov ID
- NCT02186535
- Acronym / sponsor ID
- A14-131
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2014 (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.
The purpose of this study is to assess the impact of approximately 8 weeks of Vitamin D (VitD) and calcium supplementation, using daily versus weekly supplementation regimens, on female reproductive tract immunity.
Detailed description
This outpatient open label study will assess the impact of 8 weeks of daily versus weekly VitD and calcium supplementation on measures of cervicovaginal (CV) innate immune function, including antimicrobial and proinflammatory gene expression, Toll-like receptor (TLR)-mediated responses, immunohistochemical (IHC) analysis of immune cell markers, and microbiota in premenopausal women with insufficient serum VitD levels at baseline.
Women will be seen in 3 study visits and will be contacted by one scheduled follow-up telephone call after their final study visit. Volunteers will be consented at Visit 1 and undergo procedures to confirm they are eligible to continue in the study.
Once it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, baseline blood and genital samples will be taken in the luteal phase at Visit 2. The participant will then be given their first dose of VitD 4000 IU daily or 50,000 IU weekly in capsule form, which they will then administer for 8 weeks. Participants will also administer 1000 mg of calcium daily. Participants will return upon completion of supplementation for repeat of blood and genital samples (Visit 3).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily dosing | Other | Dietary Supplement: Vitamin D and CalciumDaily oral capsule of Vitamin D in 4000 IU/day with daily oral capsules of 1000mg of calcium |
| weekly dosing | Other | Dietary Supplement: Vitamin D and CalciumOral capsule Vitamin D 50,000 IU/week with a oral capsule of 1000mg of calcium, daily |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Serum 25(OH)D ≤ 25ng/mL (62 nmol/L)
- In good health, as evidenced by history and procedures at screening visits without any clinically significant systemic disease.
- Not at risk of an STI, meaning: In a monogamous heterosexual or same sex relationship with a partner who is not known to be HIV positive and has no known risks for STIs, or Sexually abstinent
- Willing and able to comply with study procedures
- 21 to 50 years of age
Key exclusion criteria (18 listed)
- A clinically significant history of an abnormal Pap test (by written report) in the past year that has not been evaluated and/or treated, if indicated, according to standard guidelines
- Surgery or biopsy of the vagina or cervix within 14 days
- Current STI or lower genital tract infection including HIV-1, Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Neisseria Gonorrhoeae (NG), Hepatitis B, yeast vaginitis or bacterial vaginosis (BV) (by Nugent score of 7 - 10); this does not include asymptomatic HSV or human papilloma virus (HPV)
- Current presence of vulvar, anal and/or vaginal genital warts
- Current tobacco use of any amount
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 D and Calcium | Dietary supplement | Daily dosing, weekly dosing |
Primary outcome
Vitamin D concentrations in serum and vaginal secretions
Time frame: over 8 weeks of use
Assess the impact of daily versus weekly Vitamin D and calcium supplementation regimens on Vitamin D concentrations in serum and on soluble markers innate mucosal immunity and inflammatory response in cervicovaginal secretions.
2 secondary outcomes
Assessment of Gene Expression
Time frame: over 8 weeks of use
Assessment of immune cell activation and phenotype by IHC in CV tissues
Time frame: over 8 weeks of use
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 8 Jan 2016.
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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.
Andrea Thurman, M.D. principal investigator
CONRAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D and Calcium in people with Vitamin D Deficiency, run by CONRAD 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 8 inclusion and 18 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 8 Jan 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vitamin D concentrations in serum and vaginal secretions (time frame: over 8 weeks of use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2016.