Vitamin D Status and Metabolism in Human Pregnancy
9. Februar 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
47
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New York
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Ithaca, New York, Vereinigte Staaten, 14853
- Human Metabolic Research Unit, Cornell University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
The study population consists of all healthy third-trimester pregnant (n=26) and nonpregnant (n=21) women who participated in the original RCT study.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Maternal circulating concentrations of 25-hydroxyvitamin D
Zeitfenster: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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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.
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Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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Maternal circulating concentrations of 1,25-dihydroxyvitamin D
Zeitfenster: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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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.
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Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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Maternal circulating concentrations 24,25-dihydroxyvitamin D
Zeitfenster: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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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.
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Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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Placental mRNA abundance of 25-hydroxylase
Zeitfenster: Delivery
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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.
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Delivery
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Placental mRNA abundance of 24-hydroxylase
Zeitfenster: Delivery
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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.
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Delivery
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Placental 25-hydroxyvitamin D
Zeitfenster: Delivery
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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.
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Delivery
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Placental 24,25-dihydroxyvitamin D
Zeitfenster: Delivery
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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.
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Delivery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Maternal circulating intact parathyroid hormone
Zeitfenster: Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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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.
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Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)
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Maternal circulating carboxy-terminal cross-linking telopeptide of type 1 collagen
Zeitfenster: Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
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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.
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Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
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Maternal urinary deoxypyridinoline/creatinine
Zeitfenster: Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation)
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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.
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Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation)
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Maternal circulating osteocalcin
Zeitfenster: Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
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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.
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Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Marie Caudill, PhD, Cornell University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Januar 2009
Primärer Abschluss (Tatsächlich)
18. Dezember 2010
Studienabschluss (Tatsächlich)
18. Dezember 2011
Studienanmeldedaten
Zuerst eingereicht
7. Februar 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Februar 2017
Zuerst gepostet (Tatsächlich)
14. Februar 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Februar 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Februar 2017
Zuletzt verifiziert
1. Februar 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- OSP 74161
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