Gestational HypertensionPhase 4NCT02920593
A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy
A Phase 4 study testing Vitamin D3 in people with Gestational Hypertension and Toxemia, run by Stony Brook University at 1 site in United States.
Trial summary
The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the incidence of hypertensive disorders of pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Hypertension, Toxemia, Superimposed Preeclampsia
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 31 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- With a confirmed intrauterine pregnancy, less than 16 weeks gestation
- Carrying a singleton gestation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SUNY Stony Brook Hospital
Stony Brook, New York, 11794
Diana J Garretto, MD, 631-444-7650, diana.garretto@stonybrookmedicine.edu
Malini D Persad, MD MPH, (631) 444-7650, malini.persad@stonybrookmedicine.edu
About this study
The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the incidence of hypertensive disorders of pregnancy.
Read the detailed description
Optimizing Vitamin D status during pregnancy it thought to have maternal, fetal, and neonatal benefit. Studies suggest that Vitamin D acts well beyond its most commonly thought of role in establishing calcium homeostasis and maintaining maternal and neonatal skeletal integrity. Vitamin D has also been found to modulate the maternal renal renin-angiotensin system, maternal immune response, placental implantation and function, and angiogenesis. In light of this, it is no surprise that the 2010 systematic review of vitamin D in pregnancy suggested that Vitamin D deficiency may be associated with an increase risk in maternal and neonatal morbidity. For example, vitamin D deficiency has correlated with an array of maternal conditions, including gestational hypertension, preeclampsia, gestational diabetes, myopathy, vaginal infection, and mental disease. Associated neonatal risks include preterm birth, immunosuppression, infection, low birth weight, hypokalemia, neonatal seizures, asthma, fractures and rickets.
Unfortunately, Vitamin D deficiency in pregnancy is an ongoing epidemic, affecting as many as 82% of pregnant women. While studies on Vitamin D supplementation in pregnancy have consistently shown an associated increase in maternal and neonatal serum Vitamin D levels, some studies have also suggested a concurrent decrease in adverse maternal and neonatal outcomes. For example, Vitamin D supplementation in pregnancies with known deficiency has been shown to decrease the incidence of preeclampsia as much as 32%. Other studies, on the other hand, have suggested no benefit. The inconsistency in findings lie in the fact that these studies were primarily observational in nature and plagued by small sample sizes, recall bias, and inability to adjust for potential confounders. Given this, interpretation regarding clinical significance is limited, preventing providers from making appropriate recommendations to their patients. As such, the American Congress of Obstetricians and Gynecologists (ACOG) has called for high quality studies to address whether the use of Vitamin D supplementation beyond that found in prenatal vitamins is beneficial.
In an effort to elucidate the potential benefit of Vitamin D supplementation in an unscreened population, the investigators propose conducting a randomized control trial in which Vitamin D prophylaxis is provided to a cohort of pregnant women regardless of their Vitamin D status. The aims of the study, therefore, are to:
Specific Aim 1: Determine if Vitamin D prophylaxis in pregnant women decreases the incidence of hypertensive disorders of pregnancy.
Specific Aim 2: Compare neonatal outcomes in those who received Vitamin D prophylaxis to those who did not receive Vitamin D prophylaxis.
Specific Aim 3: Compare placental histology and inflammatory markers in those who received Vitamin D prophylaxis to those who did not receive Vitamin D prophylaxis.
- Being tested
- Vitamin D3
- Keywords
- Vitamin D; hypertensive disorders of pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced, Toxemia, Eclampsia, HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vitamin D
Vitamin D prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin D3 |
| No Vitamin D Prophylaxis | No intervention | Participants will not receive additional Vitamin D in the pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The number of participants with an adverse neonatal outcome will be determined by the presence of any of the following pregnancy characteristics: preterm birth <37 weeks; Apgar score <5 at 1 minute, <7 at 5 minutes; low birth weight <2500g; neonatal intensive care unit admission; fetal distress; respiratory distress syndrome; ventilation; neonatal infection; fracture; and neonatal death. The outcome will be dichotomized and coded as present or absent.
Measured: 2 years
Placental pathology in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
The number of participants with abnormal placental evaluation will be based on the presence of any of the following: placental abruption, infarction, hypoxia, decidual vasculopathy, or thrombosis of fetal vessels. The outcome will be dichotomized and coded as present or absent.
Measured: 2 years
Placental TNF-alpha in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Number value of placental TNF-alpha level (ng/mL)
Measured: 2 years
Placental inflammatory marker IL-6 in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Number value of placental IL-6 (ng/mL)
Measured: 2 years
Placental inflammatory marker IFN-gamma in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Number value of IFN-gamma (ng/mL)
Measured: 2 years
Placental inflammatory marker GMSCF-2 in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Number value of GMSCF-2 (ng/mL)
Measured: 2 years
Placental inflammatory marker endometrial growth factor in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Number value of endometrial growth factor (ng/mL)
Measured: 2 years
Maternal Vitamin D level in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Number value of maternal serum levels of 25(OH)D (ng/mL)
Measured: 1.5 years
Cord blood Vitamin D level in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Number value of cord blood levels of 25(OH)D (ng/mL)
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana J Garretto, MD, Principal investigator, SUNY Stony Brook Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920593
- Sponsor's protocol ID
- 875799-3
- Status last verified
- Oct 2017
- First submitted
- 9 Sep 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21691184Bodnar 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.
PubMed 17535985Shin 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.
PubMed 20863562Haugen 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.
PubMed 19451820Urrutia RP, Thorp JM. Vitamin D in pregnancy: current concepts. Curr Opin Obstet Gynecol. 2012 Mar;24(2):57-64. doi: 10.1097/GCO.0b013e3283505ab3.
PubMed 22327734Hollis 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.
PubMed 21706518Shand 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.
PubMed 21040394Johnson 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.
PubMed 20640974Ringrose 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.
PubMed 21631991Powe 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.
PubMed 20733087Specker B. Vitamin D requirements during pregnancy. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1740S-7S. doi: 10.1093/ajcn/80.6.1740S.
PubMed 15585798Burton 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.
PubMed 24290528Liu 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.
PubMed 21482732Androutsopoulos 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.
PubMed 23825981Ertl 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.
PubMed 22261570
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT02920593
- Acronym / sponsor ID
- 875799-3
- Keywords
- Vitamin D; hypertensive disorders of pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the incidence of hypertensive disorders of pregnancy.
Detailed description
Optimizing Vitamin D status during pregnancy it thought to have maternal, fetal, and neonatal benefit. Studies suggest that Vitamin D acts well beyond its most commonly thought of role in establishing calcium homeostasis and maintaining maternal and neonatal skeletal integrity. Vitamin D has also been found to modulate the maternal renal renin-angiotensin system, maternal immune response, placental implantation and function, and angiogenesis. In light of this, it is no surprise that the 2010 systematic review of vitamin D in pregnancy suggested that Vitamin D deficiency may be associated with an increase risk in maternal and neonatal morbidity. For example, vitamin D deficiency has correlated with an array of maternal conditions, including gestational hypertension, preeclampsia, gestational diabetes, myopathy, vaginal infection, and mental disease. Associated neonatal risks include preterm birth, immunosuppression, infection, low birth weight, hypokalemia, neonatal seizures, asthma, fractures and rickets.
Unfortunately, Vitamin D deficiency in pregnancy is an ongoing epidemic, affecting as many as 82% of pregnant women. While studies on Vitamin D supplementation in pregnancy have consistently shown an associated increase in maternal and neonatal serum Vitamin D levels, some studies have also suggested a concurrent decrease in adverse maternal and neonatal outcomes. For example, Vitamin D supplementation in pregnancies with known deficiency has been shown to decrease the incidence of preeclampsia as much as 32%. Other studies, on the other hand, have suggested no benefit. The inconsistency in findings lie in the fact that these studies were primarily observational in nature and plagued by small sample sizes, recall bias, and inability to adjust for potential confounders. Given this, interpretation regarding clinical significance is limited, preventing providers from making appropriate recommendations to their patients. As such, the American Congress of Obstetricians and Gynecologists (ACOG) has called for high quality studies to address whether the use of Vitamin D supplementation beyond that found in prenatal vitamins is beneficial.
In an effort to elucidate the potential benefit of Vitamin D supplementation in an unscreened population, the investigators propose conducting a randomized control trial in which Vitamin D prophylaxis is provided to a cohort of pregnant women regardless of their Vitamin D status. The aims of the study, therefore, are to:
Specific Aim 1: Determine if Vitamin D prophylaxis in pregnant women decreases the incidence of hypertensive disorders of pregnancy.
Specific Aim 2: Compare neonatal outcomes in those who received Vitamin D prophylaxis to those who did not receive Vitamin D prophylaxis.
Specific Aim 3: Compare placental histology and inflammatory markers in those who received Vitamin D prophylaxis to those who did not receive Vitamin D prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Prophylaxis | Experimental | Drug: Vitamin D3Participants will be provided Vitamin D 3000 IU daily or Vitamin D 4000 IU daily with and without concurrent use of prenatal vitamins, respectively. |
| No Vitamin D Prophylaxis | No intervention | –Participants will not receive additional Vitamin D in the pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- With a confirmed intrauterine pregnancy, less than 16 weeks gestation
- Carrying a singleton gestation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Vitamin DVitamin D prophylaxis | Drug | Vitamin D Prophylaxis |
Primary outcome
Vitamin D prophylaxis in pregnant women and incidence of hypertensive disorders of pregnancy
Time frame: 1.5 years
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.
9 secondary outcomes
Adverse neonatal outcome in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 2 years
Placental pathology in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 2 years
Placental TNF-alpha in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 2 years
Placental inflammatory marker IL-6 in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 2 years
Placental inflammatory marker IFN-gamma in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 2 years
Placental inflammatory marker GMSCF-2 in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 2 years
Placental inflammatory marker endometrial growth factor in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 2 years
Maternal Vitamin D level in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 1.5 years
Cord blood Vitamin D level in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Background: PubMed 21691184ACOG Committee Opinion No. 495: Vitamin D: Screening and supplementation during pregnancy. Obstet Gynecol. 2011 Jul;118(1):197-198. doi: 10.1097/AOG.0b013e318227f06b.
- Background: PubMed 17535985Bodnar 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.
- Background: PubMed 20863562Shin 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.
- Background: PubMed 19451820Haugen 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.
- Background: PubMed 22327734Urrutia RP, Thorp JM. Vitamin D in pregnancy: current concepts. Curr Opin Obstet Gynecol. 2012 Mar;24(2):57-64. doi: 10.1097/GCO.0b013e3283505ab3.
- Background: PubMed 21706518Hollis 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.
- Background: PubMed 21040394Shand 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.
- Background: PubMed 20640974Johnson 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.
- Background: PubMed 21631991Ringrose 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.
- Background: PubMed 20733087Powe 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.
- Background: PubMed 15585798Specker B. Vitamin D requirements during pregnancy. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1740S-7S. doi: 10.1093/ajcn/80.6.1740S.
- Background: PubMed 24290528Burton 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana J Garretto, MD principal investigator
SUNY Stony Brook Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 in people with Gestational Hypertension and Toxemia, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana J Garretto, MD ((631) 444-7650, diana.garretto@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D prophylaxis in pregnant women and incidence of hypertensive disorders of pregnancy (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920593, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.