Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-31 @ 8:12 AM
Study NCT ID:
NCT02186535
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2014-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Vitamin D in Female Reproductive Tract Immunity
Sponsor:
CONRAD
Organization:
Study Overview
Official Title:
The Role of Vitamin D in Female Reproductive Tract Immunity
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: