Pregnancy, Vitamin D Deficiency
Conditions
Keywords
pregnancy, Mongolia, Vitamin D, preeclampsia
Brief summary
A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.
Detailed description
Vitamin D deficiency (serum 25(OH)D levels \<20 ng/ml or 50 nmol/l) is widespread among Mongolians and is nearly universal during the winter months. The investigators have conducted a series of studies which have shown nearly universal Vitamin D deficiency in the winter months. Observational studies in the U.S. have linked low 25(OH)D levels in women to a higher risk of preeclampsia. Mongolians also report levels of preeclampsia that are 3 times higher than those in the U.S (official reports cite 15%, though this may include gestational hypertension). Given the widespread Vitamin D deficiency in Mongolian women, the high prevalence of hypertensive pregnancy in Mongolia, and the observational studies linking low 25(OH)D levels with preeclampsia risk, the investigators are conducting a pilot Vitamin D dosing trial to: * Determine what level of Vitamin D supplementation is needed to secure 25(OH)D levels of at least 20 ng/ml in pregnant Mongolian women * Generate preliminary data in support of a funding application for a larger trial of Vitamin D supplements to prevent preeclampsia in Mongolia A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases. The investigators will enroll 360 women who plan to receive their prenatal care and deliver at Zuun Kharaa Hospital in the Selenge province in northern Mongolia. Enrollment will be stratified by season. 120 women will be randomized to each of the three doses of vitamin D (600, 2000, 4000 IU) included in a standard prenatal vitamin. Calcemia will be monitored two months after randomization and weeks 36-40 of pregnancy. Adverse events of pregnancy will be reported to the Data Safety and Monitoring Board (DSMB) and Institutional Review Board (IRB) per protocol. Data will be gathered by a Mongolian study coordinator and local clinicians. A DSMB comprised of a U.S. and Mongolian clinicians and statisticians will monitor study data for safety.
Interventions
DIETARY_SUPPLEMENT600 IU Vitamin D3 in prenatal vitamin
Women will receive 600 IU 25(OH)D in prenatal vitamin.
DIETARY_SUPPLEMENT2000 IU Vitamin D3 in prenatal vitamin
Women will receive 2000 IU 25(OH)D in prenatal vitamin.
DIETARY_SUPPLEMENT4000 IU Vitamin D3 in prenatal vitamin
Women will receive 4000 IU 25(OH)D in prenatal vitamin.
Sponsors
National Center for Maternal and Child Health Research, Mongolia
Zuun Kharaa Hospital
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older * 12-16 weeks pregnant * Receiving prenatal care at Zuun Kharaa Hospital and planning to deliver at Zuun Kharaa Hospital * Willing not to take any additional vitamin D supplements, other than the study dispensed pills
Exclusion criteria
* Existing known seizure disorder, renal failure, parathyroid disease, thyroid disease, sarcoidosis, cancer, or tuberculosis. (Tuberculosis is routinely screened in pregnancy) * History of kidney stones * Known sensitivity to multivitamin preparations * Taking vitamin D supplements containing \>600 IU/day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Serum 25(OH)D Concentration | 36 weeks gestation or delivery, if delivery occurred before 36 weeks | Circulating vitamin D at the end of the study as measured by VIDAS® enzyme linked fluorescent assay (ELFA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Monthly Blood Pressure | During pregnancy | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were measured in mm Hg at each antenatal care visit by the Study Coordinator, using the Omron- Elite 7300 (Omron Healthcare, Bannockburn, Illinois, USA) automated blood pressure monitor. Three blood pressure readings were taken after at least five minutes seated rest. For the analysis of mean blood pressures at each antenatal visit, the three readings were averaged for each participant. |
| Arterial Tonometry | 36 weeks gestation | Investigators will assess Augmentation Index (AIx) and Pulse Wave Velocity (PWV) by study arm, as measured by AtCor Medical SphygmoCor device. THIS TONOMETER FAILED AND COULD NOT BE REPAIRED, SO WE ARE NOT PRESENTING THESE DATA AS OUTCOMES. |
| Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis | During pregnancy | Gestational age was determined clinically by last menstrual period and by routine first trimester ultrasound which was universal; where these differed by more than 10 days, the ultrasound date was used. Gestational age at delivery was recorded by clinicians and rounded to the nearest week. Preterm delivery was defined as delivery before the 37th week of gestation. |
| Casarean Section as Measured by Medical Record Abstraction | Delivery | Cesarean section was abstracted from the labor and delivery chart. |
| Assisted Vaginal Delivery as Measured by Medical Record Abstraction | Delivery | Assisted vaginal delivery with forceps delivery was abstracted from the labor and delivery chart. |
| Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction | Delivery | SGA defined by the lowest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study |
| The Number of Participants With Preeclampsia | After 20 weeks gestation | Preeclampsia as measured by new onset hypertension after 20 weeks gestation and proteinuria. |
| Mean Calcemia as Measured by Serum Calcium Test (2mo) | 2 months after randomization | Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany) |
| Number of Patients With Proteinuria as Measured by Urine Dipstick | 36-40 weeks gestation/delivery | Proteinuria at last antenatal visit (usually 36-40 weeks' gestation), measured by 1+ Standard Diagnostics UroColor 10 10 (Kyonggi-do, South Korea) reagent strips |
| Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis | During pregnancy | In Mongolia, clinician-diagnosed preeclampsia may include a blood pressure increases \>30 mm Hg above early pregnancy, with or without documented hypertension, proteinuria, or symptoms such as headache and edema |
| Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount | During pregnancy | Bacterial vaginosis was routinely screened by potassium hydroxide wet mount at the first antenatal visit, at 28 weeks' and 32 weeks' gestation. It was also diagnosed by whiff test. We included both wet mount and whiff test positive in the bacterial vaginosis endpoint |
| Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks) | 36-40 weeks of pregnancy/delivery | Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany) |
| Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction | Delivery | LGA defined by the highest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study |
Countries
Mongolia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 600 IU Women will receive prenatal vitamins containing 600 IU of Vitamin D.
Dietary supplement: 600 IU Vitamin D3 in prenatal vitamin | 119 |
| 2000 IU Women will receive prenatal vitamins containing 2000 IU of Vitamin D.
Dietary supplement: 2000 IU Vitamin D in prenatal vitamin | 121 |
| 4000 IU Women will receive prenatal vitamins containing 4000 IU of Vitamin D.
Dietary supplement: 4000 IU Vitamin D3 in prenatal vitamin | 120 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Fetal Loss | 2 | 3 | 1 |
| Overall Study | Moved where blood couldn't be collected | 4 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | 600 IU | 2000 IU | 4000 IU | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 121 Participants | 120 Participants | 360 Participants |
| Sex: Female, Male Female | 119 Participants | 121 Participants | 120 Participants | 360 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 121 | 0 / 120 |
| other Total, other adverse events | 0 / 119 | 0 / 121 | 0 / 120 |
| serious Total, serious adverse events | 0 / 119 | 0 / 121 | 0 / 120 |
Outcome results
Primary
Total Serum 25(OH)D Concentration
Circulating vitamin D at the end of the study as measured by VIDAS® enzyme linked fluorescent assay (ELFA)
Time frame: 36 weeks gestation or delivery, if delivery occurred before 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 600 IU | Total Serum 25(OH)D Concentration | 46 nmol/l | Standard Deviation 21 |
| 2000 IU | Total Serum 25(OH)D Concentration | 70 nmol/l | Standard Deviation 23 |
| 4000 IU | Total Serum 25(OH)D Concentration | 81 nmol/l | Standard Deviation 29 |
Secondary
Arterial Tonometry
Investigators will assess Augmentation Index (AIx) and Pulse Wave Velocity (PWV) by study arm, as measured by AtCor Medical SphygmoCor device. THIS TONOMETER FAILED AND COULD NOT BE REPAIRED, SO WE ARE NOT PRESENTING THESE DATA AS OUTCOMES.
Time frame: 36 weeks gestation
Secondary
Assisted Vaginal Delivery as Measured by Medical Record Abstraction
Assisted vaginal delivery with forceps delivery was abstracted from the labor and delivery chart.
Time frame: Delivery
Population: Women who delivered after 20 weeks at the study hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Assisted Vaginal Delivery as Measured by Medical Record Abstraction | 0 Participants |
| 2000 IU | Assisted Vaginal Delivery as Measured by Medical Record Abstraction | 0 Participants |
| 4000 IU | Assisted Vaginal Delivery as Measured by Medical Record Abstraction | 0 Participants |
Secondary
Average Monthly Blood Pressure
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were measured in mm Hg at each antenatal care visit by the Study Coordinator, using the Omron- Elite 7300 (Omron Healthcare, Bannockburn, Illinois, USA) automated blood pressure monitor. Three blood pressure readings were taken after at least five minutes seated rest. For the analysis of mean blood pressures at each antenatal visit, the three readings were averaged for each participant.
Time frame: During pregnancy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 600 IU | Average Monthly Blood Pressure | DBP wk 24-28 | 64.2 mmHg | Standard Deviation 9.8 |
| 600 IU | Average Monthly Blood Pressure | SBP wk 24-28 | 104.9 mmHg | Standard Deviation 9.1 |
| 600 IU | Average Monthly Blood Pressure | DBP wk 28-32 | 64.4 mmHg | Standard Deviation 8.7 |
| 600 IU | Average Monthly Blood Pressure | DBP wk 32-36 | 67.2 mmHg | Standard Deviation 8.8 |
| 600 IU | Average Monthly Blood Pressure | SBP wk 28-32 | 104.5 mmHg | Standard Deviation 8.7 |
| 600 IU | Average Monthly Blood Pressure | DBP wk 36-40 | 70.4 mmHg | Standard Deviation 9.7 |
| 600 IU | Average Monthly Blood Pressure | SBP wk 16-20 | 104.5 mmHg | Standard Deviation 9.2 |
| 600 IU | Average Monthly Blood Pressure | SBP wk 36-40 | 110.8 mmHg | Standard Deviation 10.1 |
| 600 IU | Average Monthly Blood Pressure | SBP wk 20-24 | 105.1 mmHg | Standard Deviation 9 |
| 600 IU | Average Monthly Blood Pressure | DBP wk 16-20 | 63.8 mmHg | Standard Deviation 8.7 |
| 600 IU | Average Monthly Blood Pressure | DBP wk 20-24 | 63.2 mmHg | Standard Deviation 9 |
| 2000 IU | Average Monthly Blood Pressure | SBP wk 20-24 | 103.6 mmHg | Standard Deviation 8.2 |
| 2000 IU | Average Monthly Blood Pressure | DBP wk 24-28 | 62.6 mmHg | Standard Deviation 9.4 |
| 2000 IU | Average Monthly Blood Pressure | SBP wk 36-40 | 110.6 mmHg | Standard Deviation 9.5 |
| 2000 IU | Average Monthly Blood Pressure | DBP wk 28-32 | 63.6 mmHg | Standard Deviation 9.2 |
| 2000 IU | Average Monthly Blood Pressure | SBP wk 24-28 | 103.3 mmHg | Standard Deviation 8.1 |
| 2000 IU | Average Monthly Blood Pressure | DBP wk 20-24 | 63.1 mmHg | Standard Deviation 8.6 |
| 2000 IU | Average Monthly Blood Pressure | DBP wk 32-36 | 66.5 mmHg | Standard Deviation 9.4 |
| 2000 IU | Average Monthly Blood Pressure | SBP wk 16-20 | 104.5 mmHg | Standard Deviation 8.7 |
| 2000 IU | Average Monthly Blood Pressure | DBP wk 16-20 | 63.7 mmHg | Standard Deviation 8.7 |
| 2000 IU | Average Monthly Blood Pressure | DBP wk 36-40 | 71.0 mmHg | Standard Deviation 10.2 |
| 2000 IU | Average Monthly Blood Pressure | SBP wk 28-32 | 103.9 mmHg | Standard Deviation 9.7 |
| 4000 IU | Average Monthly Blood Pressure | DBP wk 36-40 | 71.7 mmHg | Standard Deviation 10.6 |
| 4000 IU | Average Monthly Blood Pressure | SBP wk 16-20 | 105.5 mmHg | Standard Deviation 9.7 |
| 4000 IU | Average Monthly Blood Pressure | SBP wk 20-24 | 105.4 mmHg | Standard Deviation 8.9 |
| 4000 IU | Average Monthly Blood Pressure | SBP wk 28-32 | 105.4 mmHg | Standard Deviation 9.3 |
| 4000 IU | Average Monthly Blood Pressure | SBP wk 36-40 | 111.1 mmHg | Standard Deviation 11 |
| 4000 IU | Average Monthly Blood Pressure | DBP wk 16-20 | 65.2 mmHg | Standard Deviation 9 |
| 4000 IU | Average Monthly Blood Pressure | DBP wk 20-24 | 63.8 mmHg | Standard Deviation 9.6 |
| 4000 IU | Average Monthly Blood Pressure | DBP wk 24-28 | 63.5 mmHg | Standard Deviation 9.6 |
| 4000 IU | Average Monthly Blood Pressure | DBP wk 28-32 | 65.1 mmHg | Standard Deviation 9.2 |
| 4000 IU | Average Monthly Blood Pressure | DBP wk 32-36 | 67.1 mmHg | Standard Deviation 9.5 |
| 4000 IU | Average Monthly Blood Pressure | SBP wk 24-28 | 104.0 mmHg | Standard Deviation 9.3 |
p-value: 0.7ANOVA
Secondary
Casarean Section as Measured by Medical Record Abstraction
Cesarean section was abstracted from the labor and delivery chart.
Time frame: Delivery
Population: Women who delivered after 20 weeks at study hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Casarean Section as Measured by Medical Record Abstraction | 22 Participants |
| 2000 IU | Casarean Section as Measured by Medical Record Abstraction | 27 Participants |
| 4000 IU | Casarean Section as Measured by Medical Record Abstraction | 26 Participants |
p-value: 0.79Chi-squared
Secondary
Mean Calcemia as Measured by Serum Calcium Test (2mo)
Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany)
Time frame: 2 months after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 600 IU | Mean Calcemia as Measured by Serum Calcium Test (2mo) | 2.2 mmol/L | Standard Deviation 0.2 |
| 2000 IU | Mean Calcemia as Measured by Serum Calcium Test (2mo) | 2.2 mmol/L | Standard Deviation 0.2 |
| 4000 IU | Mean Calcemia as Measured by Serum Calcium Test (2mo) | 2.2 mmol/L | Standard Deviation 0.2 |
p-value: 0.24ANOVA
Secondary
Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks)
Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany)
Time frame: 36-40 weeks of pregnancy/delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 600 IU | Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks) | 2.3 mmol/L | Standard Deviation 0.2 |
| 2000 IU | Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks) | 2.3 mmol/L | Standard Deviation 0.2 |
| 4000 IU | Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks) | 2.3 mmol/L | Standard Deviation 0.2 |
Secondary
Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction
LGA defined by the highest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study
Time frame: Delivery
Population: Singleton deliveries after 20 weeks at study hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction | 25 Participants |
| 2000 IU | Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction | 26 Participants |
| 4000 IU | Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction | 33 Participants |
p-value: 0.39Chi-squared
Secondary
Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount
Bacterial vaginosis was routinely screened by potassium hydroxide wet mount at the first antenatal visit, at 28 weeks' and 32 weeks' gestation. It was also diagnosed by whiff test. We included both wet mount and whiff test positive in the bacterial vaginosis endpoint
Time frame: During pregnancy
Population: Women seen for antenatal care during the trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount | 17 Participants |
| 2000 IU | Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount | 19 Participants |
| 4000 IU | Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount | 18 Participants |
p-value: 0.95Chi-squared
Secondary
Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis
In Mongolia, clinician-diagnosed preeclampsia may include a blood pressure increases \>30 mm Hg above early pregnancy, with or without documented hypertension, proteinuria, or symptoms such as headache and edema
Time frame: During pregnancy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis | 4 Participants |
| 2000 IU | Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis | 3 Participants |
| 4000 IU | Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis | 3 Participants |
p-value: 0.89Chi-squared
Secondary
Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis
Gestational age was determined clinically by last menstrual period and by routine first trimester ultrasound which was universal; where these differed by more than 10 days, the ultrasound date was used. Gestational age at delivery was recorded by clinicians and rounded to the nearest week. Preterm delivery was defined as delivery before the 37th week of gestation.
Time frame: During pregnancy
Population: Women delivering after 20 weeks at study hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis | 9 Participants |
| 2000 IU | Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis | 8 Participants |
| 4000 IU | Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis | 5 Participants |
p-value: 0.49Chi-squared
Secondary
Number of Patients With Proteinuria as Measured by Urine Dipstick
Proteinuria at last antenatal visit (usually 36-40 weeks' gestation), measured by 1+ Standard Diagnostics UroColor 10 10 (Kyonggi-do, South Korea) reagent strips
Time frame: 36-40 weeks gestation/delivery
Population: Women who attended a last clinical visit after 36 weeks and gave a urine sample
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Number of Patients With Proteinuria as Measured by Urine Dipstick | 2 Participants |
| 2000 IU | Number of Patients With Proteinuria as Measured by Urine Dipstick | 2 Participants |
| 4000 IU | Number of Patients With Proteinuria as Measured by Urine Dipstick | 0 Participants |
p-value: 0.39Chi-squared
Secondary
Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction
SGA defined by the lowest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study
Time frame: Delivery
Population: Singleton deliveries at study hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction | 1 Participants |
| 2000 IU | Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction | 2 Participants |
| 4000 IU | Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction | 2 Participants |
p-value: 0.83Chi-squared
Secondary
The Number of Participants With Preeclampsia
Preeclampsia as measured by new onset hypertension after 20 weeks gestation and proteinuria.
Time frame: After 20 weeks gestation
Population: Women delivering after 20 weeks in study hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 600 IU | The Number of Participants With Preeclampsia | 1 Participants |
| 2000 IU | The Number of Participants With Preeclampsia | 0 Participants |
| 4000 IU | The Number of Participants With Preeclampsia | 0 Participants |