Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Change in maternal biomarkers during pregnancy up to 28 weeks
研究概览
简要总结
This is a prospective, randomized, placebo controlled study with three parallel arms examining the effects of magnesium supplementation in the second trimester of pregnancy.
Recent research has shown that supplemental magnesium can have beneficial effects, especially in overweight individuals. Not only do many people have a magnesium deficient diet, there is also evidence that magnesium can improve blood sugar levels. Due to the growing concern of obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes.
In this study, 60 overweight and obese pregnant patients in their first trimester will be enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg elemental Magnesium), group B will receive dietary counseling about following a magnesium rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine specimens will be collected at three time points during the pregnancy to analyze changes in levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal and maternal complications of pregnancy will be noted, including maternal weight gain. At delivery, patients will have a placental cord blood specimen and placental biopsy collected for gene expression patterns and further analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 40 years of age
- •Pregnant in the first trimester
- •Able to give informed consent
- •Planning to deliver at UCLA
- •BMI greater than or equal to 25
排除标准
- •On insulin therapy or other oral hypoglycemic agents
- •Multiple gestation
- •Baseline HgbA1C > 6.5%
- •Prior history of clinically diagnosed T2D
- •Multiple dietary restrictions/food allergies
- •Heart, renal, or liver failure
- •Clinical history of psychiatric illness or substance abuse
- •Out of town travel planned at study visits
结局指标
主要结局
Change in maternal biomarkers during pregnancy up to 28 weeks
时间窗: up to 28 weeks
Blood and urine markers of inflammatory and metabolic markers will be assessed during the pregnancy,comparing baseline values to second trimester values, which will be up to 28 weeks.
Neonatal birth weight/height
时间窗: Up to 10 months
This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. Neonatal weight and height at birth will be assessed.
Change in maternal biomarkers in pregnancy in the third trimester
时间窗: Up to 36 weeks
Blood and urine markers of inflammatory and metabolic markers will be assessed during the pregnancy,comparing baseline values to third trimester values, which will be up to 36 weeks.
次要结局
- Neonatal outcomes(Up to 10 months)
- Neonatal tertiary outcomes(Up to 10 months)
- Pregnancy complications(Up to 10 months)
研究者
Simin Liu, Dr.
Principal Investigator
University of California, Los Angeles