Vitamin D Deficiency Clinical Trial
Official title:
The Role of Vitamin D in Female Reproductive Tract Immunity
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.
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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