| NCT ID | NCT02705287 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cornell University |
| Condition | Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2024-10-28 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this project is to utilize stable isotopically labeled vitamin D3 and state of the art mass spectrometric methodology to assess vitamin D dynamics during pregnancy in relation to relation to obesity and vitamin D binding protein genotype. At the conclusion of this study, the investigators will have obtained novel information on the absorption and utilization of vitamin D in women and the degree to which vitamin D utilization during pregnancy is impacted by genetic ancestry, vitamin D binding protein concentration and genotype and by excess adiposity. The long-term goal is to better understand the unique metabolism of vitamin D during pregnancy.
Eligibility 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
Contact & Investigator
Kimberly O. O'Brien, PhD
PRINCIPAL INVESTIGATOR
Cornell University
Frequently Asked Questions
Who can join the NCT02705287 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 39 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02705287 currently recruiting?
Yes, NCT02705287 is actively recruiting participants. Contact the research team at koo4@cornell.edu for enrollment information.
Where is the NCT02705287 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT02705287 clinical trial?
NCT02705287 is sponsored by Cornell University. The principal investigator is Kimberly O. O'Brien, PhD at Cornell University. The trial plans to enroll 160 participants.