NCT02186535

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

July 1, 2014

Last Update Submit

January 7, 2016

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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.

    over 8 weeks of use

Secondary Outcomes (2)

  • Assessment of Gene Expression

    over 8 weeks of use

  • Assessment of immune cell activation and phenotype by IHC in CV tissues

    over 8 weeks of use

Study Arms (2)

Daily dosing

OTHER

Daily oral capsule of Vitamin D in 4000 IU/day with daily oral capsules of 1000mg of calcium

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

Dietary Supplement: Vitamin D and Calcium

Interventions

Vitamin D and CalciumDIETARY_SUPPLEMENT
Daily dosingweekly dosing

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Virginia Medical School CONRAD Clinical Research Center

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DCalcium

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Andrea Thurman, M.D.

    CONRAD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 10, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

US(1)