Observational Study of Vitamin D Dynamics in Women
This observational study is looking at how pregnancy, obesity, and ancestry affect how your body uses vitamin D. Researchers are giving a small, safe dose of a special type of vitamin D3 (deuterated vitamin D3) to both pregnant and non-pregnant women. They want to understand how vitamin D is absorbed and used over a 40-day period. The goal is to learn more about vitamin D metabolism during pregnancy, especially since many women have low vitamin D levels, which can be linked to problems like premature birth. This study is for women aged 20-39, who are either White or Black, and have a specific body mass index (BMI). The study is currently unclear on its recruitment status and plans to enroll 160 participants.
- Study design
- This is an observational study, meaning researchers will observe participants without assigning specific treatments. It aims to enroll 160 women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for this study are measured across a 40-day study period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vitamin D Dynamics in Women
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kimberly O. O'Brien, PhD · PRINCIPAL_INVESTIGATOR · Cornell University
- Eva Pressman, MD · PRINCIPAL_INVESTIGATOR · University of Rochester
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Impact of pregnancy on serum vitamin D absorptionAcross 40 days study period
A baseline blood sample (20 mL) will be obtained for analysis of the baseline concentrations of indicators of vitamin D status. Each woman will be asked to ingest two pieces of toast onto which a dose of 35 μg of \[6,19,19-d3\]-vitamin D3 has been added. Women will return to the at 4 hour, 8 hour, Day 2, 10, 25, and 40 (± 2 days) for an additional blood sample (15 mL each) to assess the disappearance of the tri-deuterated D3, conversion into 25(OH)D3, and serum half-life of 25(OH)D3.
- Impact of obesity on vitamin D absorptionAcross 40 days study period
A baseline blood sample (20 mL) will be obtained for analysis of the baseline concentrations of indicators of vitamin D status. Each woman will be asked to ingest two pieces of toast onto which a dose of 35 μg of \[6,19,19-d3\]-vitamin D3 has been added. Women will return to the at 4 hour, 8 hour, Day 2, 10, 25, and 40 (± 2 days) for an additional blood sample (15 mL each) to assess the disappearance of the tri-deuterated D3, conversion into 25(OH)D3, and serum half-life of 25(OH)D3. Body composition measure using Bioelectrical Impedance Analysis (BIA) will be conducted on Day 0 for all participants and Day 40 for he pregnant participants to obtain information on BMI and fat mass. Adipose tissue (\<1 gram) will be extracted using needle biopsy from the upper buttock area on all participants for D content analysis.
- Impact of ancestry on serum vitamin D absorptionAcross 40 days study period
A baseline blood sample (20 mL) will be obtained for analysis of the baseline concentrations of calcitropic hormones and indicators of vitamin D status. Each woman will be asked to ingest one quarter piece of toast onto which a dose of 35 ug of \[6,19,19-d3\]-vitamin D3 has been added. Women will return to the at 4 hour, 8 hour, Day 1, 3, 10, 25, and 40 (± 2 days) for an additional blood sample (15 mL each) to assess the disappearance of the tri-deuterated D3, conversion into 25(OH)D3, and serum half-life of 25(OH)D3. DNA will be extracted to perform ancestry genotyping and determine vitamin D binding protein genotypes.