Vitamin D Status and Metabolism in Human Pregnancy
9 lutego 2017 zaktualizowane przez: Cornell University
Vitamin D Status and Metabolism in Pregnant and Nonpregnant Control Women Consuming Controlled and Equivalent Intakes of Vitamin D
The purpose of the present study is to understand the effect of pregnancy on vitamin D metabolism and requirements as well as the modulatory role of the placenta in vitamin D metabolism during pregnancy.
In addition, a human placental cell culture model will be employed to examine vitamin D metabolic flux in human trophoblast cells.
The impact of maternal vitamin D status on maternal and fetal bone health during gestation will also be examined.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Rationale
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:
- Blood biomarkers of vitamin D metabolism at week 0 (study-baseline) and week 10 (representing study-end)
- Placental biomarkers of vitamin D metabolism at delivery
- 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.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
47
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
New York
-
Ithaca, New York, Stany Zjednoczone, 14853
- Human Metabolic Research Unit, Cornell University
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
21 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Kobieta
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
The study population consists of all healthy third-trimester pregnant (n=26) and nonpregnant (n=21) women who participated in the original RCT study.
Opis
Inclusion Criteria:
- Age of 21-40 y
- 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 tobacco, drug, or alcohol
- Use of prescription medications known to affect liver function
- Pregnancy associated complications
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maternal circulating concentrations of 25-hydroxyvitamin D
Ramy czasowe: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
Serum 25-hydroxyvitamin D [25(OH)D] will be measured using an isotope dilution LC-MS/MS methodology, and the effect of reproductive state on serum 25(OH)D will be examined using a linear mixed model which considers confounding factors.
|
Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
|
Maternal circulating concentrations of 1,25-dihydroxyvitamin D
Ramy czasowe: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
Plasma 1,25-dihydroxyvitamin D [1,25(OH)2D] will be measured using an EIA kit, and the effect of reproductive state on circulating 1,25(OH)2D will be examined using a linear mixed model which considers confounding factors.
|
Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
|
Maternal circulating concentrations 24,25-dihydroxyvitamin D
Ramy czasowe: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
Plasma 24,25-dihydroxyvitamin D [24,25(OH)2D] will be measured using an isotope dilution LC-MS/MS methodology, and the effect of reproductive state on circulating 24,25(OH)2D will be examined using a linear mixed model which considers potential confounders.
|
Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
|
Placental mRNA abundance of 25-hydroxylase
Ramy czasowe: Delivery
|
Placental mRNA abundance of 25-hydroxylase [CYP2R1] will be measured using a qPCR, and the associations of placental CYP2R1 mRNA abundance with serum 25(OH)D will be examined using a linear mixed model which considers potential confounders.
|
Delivery
|
|
Placental mRNA abundance of 24-hydroxylase
Ramy czasowe: Delivery
|
Placental mRNA abundance of 24-hydroxylase [CYP24A1] will be measured using a qPCR, and the associations of placental CYP24A1 mRNA abundance with circulating 24,25(OH)2D will be examined using a linear mixed model which considers potential confounders.
|
Delivery
|
|
Placental 25-hydroxyvitamin D
Ramy czasowe: Delivery
|
25(OH)D will be measured from placental tissue using an isotope dilution LC-MS/MS methodology, and the associations of placental 25(OH)D with serum 25(OH)D as well as placental CYP2R1 mRNA abundance will be examined using a Pearson correlation test and a linear mixed model which considers potential confounders.
|
Delivery
|
|
Placental 24,25-dihydroxyvitamin D
Ramy czasowe: Delivery
|
24,25(OH)2D will be measured from placental tissue using an isotope dilution LC-MS/MS methodology, and the associations of placental 24,25(OH)2D with circulating 25(OH)D and 24,25(OH)2D as well as placental CYP24A1 mRNA abundance will be examined using a Pearson correlation test and a linear mixed model which adjusts for potential confounders.
|
Delivery
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maternal circulating intact parathyroid hormone
Ramy czasowe: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
Plasma intact parathyroid hormone [iPTH] will be measured using an automated immunoassay, and the relationship of maternal serum 25(OH)D with maternal iPTH will be assessed using a linear mixed model which considers potential confounders.
|
Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
|
|
Maternal circulating carboxy-terminal cross-linking telopeptide of type 1 collagen
Ramy czasowe: Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
|
Plasma carboxy-terminal cross-linking telopeptide of type 1 collagen [CTx] will be measured using an ELISA kit, and the relationships of maternal serum 25(OH)D with maternal CTx will be assessed using a linear mixed model which considers potential confounders.
|
Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
|
|
Maternal urinary deoxypyridinoline/creatinine
Ramy czasowe: Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation)
|
Urinary deoxypyridinoline/creatinine [DPD/Cr] will be measured using an ELISA kit, and the relationships of maternal serum 25(OH)D with maternal DPD/Cr will be assessed using a linear mixed model which considers potential confounders.
|
Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation)
|
|
Maternal circulating osteocalcin
Ramy czasowe: Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
|
Plasma osteocalcin [OC] will be measured using an ELISA kit, and the relationships of maternal serum 25(OH)D with maternal OC will be assessed using a linear mixed model which considers potential confounders.
|
Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Marie Caudill, PhD, Cornell University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
15 stycznia 2009
Zakończenie podstawowe (Rzeczywisty)
18 grudnia 2010
Ukończenie studiów (Rzeczywisty)
18 grudnia 2011
Daty rejestracji na studia
Pierwszy przesłany
7 lutego 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 lutego 2017
Pierwszy wysłany (Rzeczywisty)
14 lutego 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 lutego 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 lutego 2017
Ostatnia weryfikacja
1 lutego 2017
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- OSP 74161
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .