Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Total Serum 25(OH)D Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Total Serum 25(OH)D Concentration
时间窗: 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)
次要结局
- The Number of Participants With Preeclampsia(After 20 weeks gestation)
- Arterial Tonometry(36 weeks gestation)
- Assisted Vaginal Delivery as Measured by Medical Record Abstraction(Delivery)
- Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction(Delivery)
- Casarean Section as Measured by Medical Record Abstraction(Delivery)
- Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount(During pregnancy)
- Average Monthly Blood Pressure(During pregnancy)
- Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis(During pregnancy)
- Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction(Delivery)
- Mean Calcemia as Measured by Serum Calcium Test (2mo)(2 months after randomization)
- Number of Patients With Proteinuria as Measured by Urine Dipstick(36-40 weeks gestation/delivery)
- Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis(During pregnancy)
- Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks)(36-40 weeks of pregnancy/delivery)
研究者
Janet Rich-Edwards
Director of Developmental Epidemiology
Brigham and Women's Hospital