Understanding vitamin D dynamics in pregnant women
Vitamin D Dynamics in Pregnant Women and Non-Pregnant Women of Reproductive Age
Cornell University · NCT02705287
This study looks at how vitamin D works in pregnant women and how things like weight and genetics affect its absorption to help improve health for moms and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 20 Years to 39 Years |
| Sex | Female |
| Sponsor | Cornell University (other) |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT02705287 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the dynamics of vitamin D during pregnancy using stable isotopically labeled vitamin D3 and advanced mass spectrometric techniques. It focuses on how factors such as obesity and vitamin D binding protein genotype affect vitamin D absorption and utilization in pregnant women. The study will gather data on vitamin D metabolism throughout different stages of pregnancy to better understand its implications for maternal and fetal health. The ultimate goal is to provide insights that could inform guidelines for vitamin D intake during pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are self-reported White and Black women aged 20-39 with a BMI within specified ranges, either pregnant or non-pregnant.
Not a fit: Patients with a BMI below 18.5 kg/m2, certain medical conditions, or those on medications affecting vitamin D metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved guidelines for vitamin D supplementation during pregnancy, potentially enhancing maternal and fetal health outcomes.
How similar studies have performed: While there is limited direct research on vitamin D dynamics in pregnant women, previous studies have indicated the importance of vitamin D in pregnancy, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Non-pregnant and pregnant participants participants): * Self-reported White and Black women * Age 20-39 * Body mass index (BMI) 1or pre-pregnancy BMI (If currently pregnant) either 18.5-24.9 kg/m2 or greater than or equal to 30 kg/m2 Inclusion Criteria (Additional criteria for pregnant participants): * Singleton pregnancy * Recruited in first trimester, second trimester, or third trimester * No pregnancy complications Exclusion Criteria (Non-pregnant and pregnant participants): * BMI or pre-pregnancy BMI \<18.5 kg/m2 * Human immunodeficiency virus (HIV) infection * Diagnosed eating disorder * Malabsorption disease * Diabetes * Elevated diastolic blood pressure (\>110 mm/Hg) * Steroid use * Substance abuse history * Current use of medications known to influence vitamin D or calcium homeostasis * Plans to travel to lower latitude during the 20-day study period * Plans to become pregnant during the study period (non-pregnant only) * Refuses to discontinue tanning bed use during study period * Refuses to discontinue vitamin or mineral supplement use during study period (non-pregnant only) Exclusion Criteria (Additional criteria for pregnant participants): * Gestational diabetes * Pregnancy hypertension
Where this trial is running
Rochester, New York
- University of Rochester, 518 Hylan Building — Rochester, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Kimberly O. O'Brien, PhD — Cornell University
- Study coordinator: Kimberly O. O'Brien, PhD
- Email: koo4@cornell.edu
- Phone: 607-255-3743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy, vitamin D, half life, kinetics