Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
47 participants
OBSERVATIONAL
2009-01-15
2011-12-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy
NCT02920593
Impact of Maternal Body Weight on Vitamin D Status During Pregnancy
NCT02713009
Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy
NCT04591847
Vitamin D and Preeclampsia
NCT01648842
Prenatal Nutrient Status Study
NCT06156826
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Despite mounting evidence that maternal vitamin D status is linked to pregnancy outcomes \[1,2\], the impact of pregnancy on vitamin D metabolism and requirement has yet to be clearly defined. In addition, although the placenta is known to express all components of the vitamin D metabolic pathway \[3,4\], very little is known about placental vitamin D metabolism. Moreover, although vitamin D is known to affect bone health in the nonpregnant state, the effect of maternal vitamin D status on maternal and fetal bone health in human pregnancy is unclear \[5-7\]. Therefore, the present study seeks to advance current understanding of vitamin D metabolism and requirements during pregnancy.
Objective and Research Questions
This study aims to examine: 1) the effect of pregnancy on a comprehensive panel of blood biomarkers of vitamin D status and metabolism; 2) the role of the placenta in modulating circulating vitamin D metabolites; and 3) the impact of maternal vitamin D status on maternal and fetal markers of bone metabolism.
Study Population, Design, and Exposure
As a secondary analysis, this study uses biological samples obtained from pregnant and nonpregnant control women who participated in a 12-wk randomized controlled trial in 2009-2010 which featured two doses of choline (i.e., 480 or 930 mg choline/d) (NCT01127022) \[8\]. Throughout the controlled feeding period, 26 third-trimester pregnant women and 21 nonpregnant women (both reproductive groups aged \> 21 y) in a good health status consumed equivalent intakes of vitamin D (511 IU/d), calcium (1.6 g/d) and phosphorus (1.9 g/d) from the study diet and prenatal multivitamin supplement (Pregnancy Plus; Fairhaven Health LLC) for ≥ 10 weeks.
Dependent variables:
1. Blood biomarkers of vitamin D metabolism at week 0 (study-baseline) and week 10 (representing study-end)
2. Placental biomarkers of vitamin D metabolism at delivery
3. Markers of bone metabolism in maternal and fetal cord blood as well as maternal urine
Ethical considerations
The study protocol of the original RCT was approved by the Institutional Review Board for Human Study Participant Use at Cornell University and the Cayuga Medical Center where pregnant women delivered their babies. Informed consent was obtained from all participants before study entry, and the original study was registered at clinicaltrials.gov as NCT01127022. For this secondary analysis, deidentified data will be used.
Dissemination Findings
Findings from the present study will be reported in manuscripts that will be submitted for publication to a leading medical/nutrition journal in an appropriate field (i.e. nutrition, bone, placenta, and reproductive physiology). In addition, findings will be presented as abstracts, posters, and presentations at research conferences.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Third-trimester pregnant women
Women differing in their reproductive state (pregnant versus nonpregnant) will consume equivalent dietary intakes of vitamin D and related nutrients as part of a feeding study.
No interventions assigned to this group
Nonpregnant control women
Women differing in their reproductive state (pregnant versus nonpregnant) will consume equivalent dietary intakes of vitamin D and related nutrients as part of a feeding study.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthiness as assessed by health-related questionnaire, a blood chemistry profile, and a complete blood count
* Normal liver and kidney function
* Willingness to comply with the study protocol
* Singleton pregnancy (pregnant women only)
Exclusion Criteria
* Use of prescription medications known to affect liver function
* Pregnancy associated complications
21 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cornell University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie Caudill, PhD
Role: PRINCIPAL_INVESTIGATOR
Cornell University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Human Metabolic Research Unit, Cornell University
Ithaca, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wagner CL, Taylor SN, Johnson DD, Hollis BW. The role of vitamin D in pregnancy and lactation: emerging concepts. Womens Health (Lond). 2012 May;8(3):323-40. doi: 10.2217/whe.12.17.
Aghajafari F, Nagulesapillai T, Ronksley PE, Tough SC, O'Beirne M, Rabi DM. Association between maternal serum 25-hydroxyvitamin D level and pregnancy and neonatal outcomes: systematic review and meta-analysis of observational studies. BMJ. 2013 Mar 26;346:f1169. doi: 10.1136/bmj.f1169.
Ma R, Gu Y, Zhao S, Sun J, Groome LJ, Wang Y. Expressions of vitamin D metabolic components VDBP, CYP2R1, CYP27B1, CYP24A1, and VDR in placentas from normal and preeclamptic pregnancies. Am J Physiol Endocrinol Metab. 2012 Oct 1;303(7):E928-35. doi: 10.1152/ajpendo.00279.2012. Epub 2012 Aug 7.
Liu NQ, Hewison M. Vitamin D, the placenta and pregnancy. Arch Biochem Biophys. 2012 Jul 1;523(1):37-47. doi: 10.1016/j.abb.2011.11.018. Epub 2011 Dec 2.
Olausson H, Goldberg GR, Laskey MA, Schoenmakers I, Jarjou LM, Prentice A. Calcium economy in human pregnancy and lactation. Nutr Res Rev. 2012 Jun;25(1):40-67. doi: 10.1017/S0954422411000187.
Kalra P, Das V, Agarwal A, Kumar M, Ramesh V, Bhatia E, Gupta S, Singh S, Saxena P, Bhatia V. Effect of vitamin D supplementation during pregnancy on neonatal mineral homeostasis and anthropometry of the newborn and infant. Br J Nutr. 2012 Sep 28;108(6):1052-8. doi: 10.1017/S0007114511006246. Epub 2012 Jan 3.
Hashemipour S, Lalooha F, Zahir Mirdamadi S, Ziaee A, Dabaghi Ghaleh T. Effect of vitamin D administration in vitamin D-deficient pregnant women on maternal and neonatal serum calcium and vitamin D concentrations: a randomised clinical trial. Br J Nutr. 2013 Nov 14;110(9):1611-6. doi: 10.1017/S0007114513001244. Epub 2013 Apr 29.
Yan J, Jiang X, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Stabler SP, Allen RH, Caudill MA. Maternal choline intake modulates maternal and fetal biomarkers of choline metabolism in humans. Am J Clin Nutr. 2012 May;95(5):1060-71. doi: 10.3945/ajcn.111.022772. Epub 2012 Mar 14.
Park H, Wood MR, Malysheva OV, Jones S, Mehta S, Brannon PM, Caudill MA. Placental vitamin D metabolism and its associations with circulating vitamin D metabolites in pregnant women. Am J Clin Nutr. 2017 Dec;106(6):1439-1448. doi: 10.3945/ajcn.117.153429. Epub 2017 Oct 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OSP 74161
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.