NCT02920593

Brief Summary

The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the incidence of hypertensive disorders of pregnancy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
412

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

September 9, 2016

Last Update Submit

October 4, 2017

Conditions

Gestational HypertensionToxemiaSuperimposed PreeclampsiaEclampsiaHELLP Syndrome

Keywords

Vitamin D; hypertensive disorders of pregnancy

Outcome Measures

Primary Outcomes (1)

  • Vitamin D prophylaxis in pregnant women and incidence of hypertensive disorders of pregnancy

    Number of participants diagnosed with a hypertensive disorder of pregnancy defined as: elevated blood pressure (systolic/diastolic \> 140/90mmHg, 2 determinations, 4 hours apart) more than 20 weeks gestation +/- new onset proteinuria (300mg/24hour; protein/creatinine ratio \> 3.0mg/dL; 1+ protein on dipstick) or abnormal labs (thrombocytopenia (platelet \< 100,000 microliter), impaired liver function testing (AST/ALT twice higher than normal), renal insufficiency (creatinine \>1.1mg/dL or doubling of creatinine in the absence of renal disease)) or pulmonary edema or seizure. The outcome will be dichotomized and coded as present or absent.

    1.5 years

Secondary Outcomes (9)

  • Adverse neonatal outcome in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis

    2 years

  • Placental pathology in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis

    2 years

  • Placental TNF-alpha in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis

    2 years

  • Placental inflammatory marker IL-6 in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis

    2 years

  • Placental inflammatory marker IFN-gamma in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis

    2 years

  • +4 more secondary outcomes

Study Arms (2)

Vitamin D Prophylaxis

EXPERIMENTAL

Participants will be provided Vitamin D 3000 IU daily or Vitamin D 4000 IU daily with and without concurrent use of prenatal vitamins, respectively.

Drug: Vitamin D3

No Vitamin D Prophylaxis

NO INTERVENTION

Participants will not receive additional Vitamin D in the pregnancy.

Interventions

Vitamin D3DRUG

Vitamin D prophylaxis

Also known as: Vitamin D
Vitamin D Prophylaxis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • With a confirmed intrauterine pregnancy, less than 16 weeks gestation
  • Carrying a singleton gestation

You may not qualify if:

  • Taking Vitamin D supplementation outside of prenatal vitamins
  • Has a known disorder that will affect vitamin D levels (i.e, hyperparathyroidism, mal-absorption disorder, history of gastric bypass surgery, immunocompromised state, maternal use of immune-modulators etc.)
  • Carrying a fetus with known aneuploidy or anomaly
  • With fetal demise
  • Women with chronic diuretic or cardiac medication therapy including calcium channel blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Stony Brook Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (17)

  • ACOG Committee Opinion No. 495: Vitamin D: Screening and supplementation during pregnancy. Obstet Gynecol. 2011 Jul;118(1):197-198. doi: 10.1097/AOG.0b013e318227f06b.

    PMID: 21691184BACKGROUND

  • Bodnar LM, Catov JM, Simhan HN, Holick MF, Powers RW, Roberts JM. Maternal vitamin D deficiency increases the risk of preeclampsia. J Clin Endocrinol Metab. 2007 Sep;92(9):3517-22. doi: 10.1210/jc.2007-0718. Epub 2007 May 29.

    PMID: 17535985BACKGROUND

  • Shin JS, Choi MY, Longtine MS, Nelson DM. Vitamin D effects on pregnancy and the placenta. Placenta. 2010 Dec;31(12):1027-34. doi: 10.1016/j.placenta.2010.08.015. Epub 2010 Sep 22.

    PMID: 20863562BACKGROUND

  • Haugen M, Brantsaeter AL, Trogstad L, Alexander J, Roth C, Magnus P, Meltzer HM. Vitamin D supplementation and reduced risk of preeclampsia in nulliparous women. Epidemiology. 2009 Sep;20(5):720-6. doi: 10.1097/EDE.0b013e3181a70f08.

    PMID: 19451820BACKGROUND

  • Urrutia RP, Thorp JM. Vitamin D in pregnancy: current concepts. Curr Opin Obstet Gynecol. 2012 Mar;24(2):57-64. doi: 10.1097/GCO.0b013e3283505ab3.

    PMID: 22327734BACKGROUND

  • Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum In: J Bone Miner Res. 2011 Dec; 26(12):3001.

    PMID: 21706518BACKGROUND

  • Shand AW, Nassar N, Von Dadelszen P, Innis SM, Green TJ. Maternal vitamin D status in pregnancy and adverse pregnancy outcomes in a group at high risk for pre-eclampsia. BJOG. 2010 Dec;117(13):1593-8. doi: 10.1111/j.1471-0528.2010.02742.x. Epub 2010 Oct 13.

    PMID: 21040394BACKGROUND

  • Johnson DD, Wagner CL, Hulsey TC, McNeil RB, Ebeling M, Hollis BW. Vitamin D deficiency and insufficiency is common during pregnancy. Am J Perinatol. 2011 Jan;28(1):7-12. doi: 10.1055/s-0030-1262505. Epub 2010 Jul 16.

    PMID: 20640974BACKGROUND

  • Ringrose JS, PausJenssen AM, Wilson M, Blanco L, Ward H, Wilson TW. Vitamin D and hypertension in pregnancy. Clin Invest Med. 2011 Jun 1;34(3):E147-54. doi: 10.25011/cim.v34i3.15187.

    PMID: 21631991BACKGROUND

  • Powe CE, Seely EW, Rana S, Bhan I, Ecker J, Karumanchi SA, Thadhani R. First trimester vitamin D, vitamin D binding protein, and subsequent preeclampsia. Hypertension. 2010 Oct;56(4):758-63. doi: 10.1161/HYPERTENSIONAHA.110.158238. Epub 2010 Aug 23.

    PMID: 20733087BACKGROUND

  • Specker B. Vitamin D requirements during pregnancy. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1740S-7S. doi: 10.1093/ajcn/80.6.1740S.

    PMID: 15585798BACKGROUND

  • Burton GJ, Sebire NJ, Myatt L, Tannetta D, Wang YL, Sadovsky Y, Staff AC, Redman CW. Optimising sample collection for placental research. Placenta. 2014 Jan;35(1):9-22. doi: 10.1016/j.placenta.2013.11.005. Epub 2013 Nov 19.

    PMID: 24290528BACKGROUND

  • Liu NQ, Kaplan AT, Lagishetty V, Ouyang YB, Ouyang Y, Simmons CF, Equils O, Hewison M. Vitamin D and the regulation of placental inflammation. J Immunol. 2011 May 15;186(10):5968-74. doi: 10.4049/jimmunol.1003332. Epub 2011 Apr 11.

    PMID: 21482732BACKGROUND

  • Androutsopoulos G, Gkogkos P, Decavalas G. Mid-trimester maternal serum HCG and alpha fetal protein levels: clinical significance and prediction of adverse pregnancy outcome. Int J Endocrinol Metab. 2013 Spring;11(2):102-6. doi: 10.5812/ijem.5014. Epub 2013 Apr 1.

    PMID: 23825981BACKGROUND

  • Ertl R, Yu CK, Samaha R, Akolekar R, Nicolaides KH. Maternal serum vitamin D at 11-13 weeks in pregnancies delivering small for gestational age neonates. Fetal Diagn Ther. 2012;31(2):103-8. doi: 10.1159/000333810. Epub 2012 Jan 18.

    PMID: 22261570BACKGROUND

  • De-Regil LM, Palacios C, Lombardo LK, Pena-Rosas JP. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2016 Jan 14;(1):CD008873. doi: 10.1002/14651858.CD008873.pub3.

    PMID: 26765344BACKGROUND

  • Roth DE. Vitamin D supplementation during pregnancy: safety considerations in the design and interpretation of clinical trials. J Perinatol. 2011 Jul;31(7):449-59. doi: 10.1038/jp.2010.203. Epub 2011 Jan 20.

    PMID: 21252966BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedToxemiaEclampsiaHELLP Syndrome

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesInfections

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Diana J Garretto, MD

    SUNY Stony Brook Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana J Garretto, MD

CONTACT

(631) 444-7650diana.garretto@stonybrookmedicine.edu

Malini D Persad, MD MPH

CONTACT

(631) 444-7650malini.persad@stonybrookmedicine.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 30, 2016

Study Start

October 1, 2016

Primary Completion

July 31, 2018

Study Completion

March 31, 2019

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

US(1)