A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy
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| ClinicalTrials.gov Identifier: NCT02920593 |
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Recruitment Status : Unknown
Verified October 2017 by Stony Brook University.
Recruitment status was: Recruiting
First Posted : September 30, 2016
Last Update Posted : October 5, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gestational Hypertension Toxemia Superimposed Preeclampsia Eclampsia HELLP Syndrome | Drug: Vitamin D3 | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 412 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy |
| Study Start Date : | October 2016 |
| Estimated Primary Completion Date : | July 31, 2018 |
| Estimated Study Completion Date : | March 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin D Prophylaxis
Participants will be provided Vitamin D 3000 IU daily or Vitamin D 4000 IU daily with and without concurrent use of prenatal vitamins, respectively.
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Drug: Vitamin D3
Vitamin D prophylaxis
Other Name: Vitamin D |
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No Intervention: No Vitamin D Prophylaxis
Participants will not receive additional Vitamin D in the pregnancy.
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- 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.
- Adverse neonatal outcome in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis [ Time Frame: 2 years ]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.
- Placental pathology in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis [ Time Frame: 2 years ]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.
- Placental TNF-alpha in those who received Vitamin D prophylaxis compared to those who did not receive Vitamin D prophylaxis [ Time Frame: 2 years ]Number value of placental TNF-alpha level (ng/mL)
- 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 ]Number value of placental IL-6 (ng/mL)
- 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 ]Number value of IFN-gamma (ng/mL)
- 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 ]Number value of GMSCF-2 (ng/mL)
- 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 ]Number value of endometrial growth factor (ng/mL)
- 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 ]Number value of maternal serum levels of 25(OH)D (ng/mL)
- 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 ]Number value of cord blood levels of 25(OH)D (ng/mL)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 18 years of age and older
- With a confirmed intrauterine pregnancy, less than 16 weeks gestation
- Carrying a singleton gestation
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920593
| Contact: Diana J Garretto, MD | (631) 444-7650 | diana.garretto@stonybrookmedicine.edu | |
| Contact: Malini D Persad, MD MPH | (631) 444-7650 | malini.persad@stonybrookmedicine.edu |
| United States, New York | |
| SUNY Stony Brook Hospital | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: Diana J Garretto, MD 631-444-7650 diana.garretto@stonybrookmedicine.edu | |
| Contact: Malini D Persad, MD MPH (631) 444-7650 malini.persad@stonybrookmedicine.edu | |
| Principal Investigator: Diana J Garretto, MD | |
| Sub-Investigator: Malini D Persad, MD | |
| Sub-Investigator: David Garry, DO | |
| Sub-Investigator: James G Quirk, MD PhD | |
| Principal Investigator: | Diana J Garretto, MD | SUNY Stony Brook Hospital |
| Responsible Party: | Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT02920593 |
| Other Study ID Numbers: |
875799-3 |
| First Posted: | September 30, 2016 Key Record Dates |
| Last Update Posted: | October 5, 2017 |
| Last Verified: | October 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Vitamin D; hypertensive disorders of pregnancy |
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Toxemia Pre-Eclampsia Eclampsia Hypertension, Pregnancy-Induced HELLP Syndrome Hypertension Vascular Diseases Cardiovascular Diseases Pregnancy Complications Infection |
Vitamin D Ergocalciferols Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |