Use of Ritual Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Folate status
研究概览
简要总结
Prenatal multivitamin/multimineral supplements (MVI) provide important nutrition supplement to the diet of pregnant women to cover potential deficiencies and optimize nutrition status of both mom and baby, especially when the diet is suboptimal or nutrient demand is high while absorption is hindered by various factors such as genetic variance and gastrointestinal function. In this double-blind, randomized, controlled trial, the investigators will recruit 70 pregnant women at gestational week 12-14 and randomly assign them to either receive a Ritual prenatal MVI (n=40) or another commercially available prenatal MVI (n=40) through out pregnancy. Both supplements are over the counter and commercially available. The major differences between the two MVIs are the chemical form of folate as either 5-methyl-tetrahydrofolate or folic acid, and the dosages of vitamin D, biotin, and docosahexaenoic acid. The investigators will collect blood samples in each trimester of pregnancy and the placenta and cord blood at delivery to assess differences in blood nutrient levels. The investigators hypothesize that consumption of Ritual MVI leads to better nutrition status and biomarkers in maternal-fetal dyads compared to control during the antepartum period.
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
- Double (Participant, Investigator)
盲法说明
Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by the pharmacy and marked with randomly generated ID numbers. Grouping will be revealed by pharmacy at end of the trial.
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
- •Pregnant women are qualified to participate if they are over 18 years of age, having singleton pregnancy, and without any of the conditions listed in the
排除标准
- •Exclusion Criteria:
- •Exclusion criteria include diabetes, cardiovascular conditions and liver disease prior to and during pregnancy because these diseases affect metabolism of several nutrients and thus may lead to differences in the MVI intake and nutrient status relationship.
研究组 & 干预措施
Ritual Epre
This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.
干预措施: Ritual Epre Multivitamin-mineral supplement (Dietary Supplement)
Control MVI
For the prenatal arm, this group will receive a control multivitamin-mineral supplement pill and a 200 mg docosahexaenoic acid (DHA) pill that are commercially available.
干预措施: control MVI (Dietary Supplement)
结局指标
主要结局
Folate status
时间窗: after 24 weeks of intervention
The investigators hypothesize that the group that consumes Ritual would have less unmetabolized folic acid in the blood than the control group. A greater proportion of participants would have supranutritional levels of folate (\> 20 ng/mL serum folate) in the control versus Ritual group.
Biotin status
时间窗: after 24 weeks of intervention
The investigators hypothesize that the group that consumes Ritual would have higher levels of biotin and lower levels of 3-HIA and 3-HIA-carnitine in the maternal and cord blood than the control group.
placental functional gene expression regulation
时间窗: after 24 weeks of intervention
The investigators hypothesize that the group that consumes Ritual would have higher expression of vitamin D response genes and lower expression of inflammatory and stress genes.
vitamin D status
时间窗: after 24 weeks of intervention
The investigators hypothesize that the group that consumes Ritual would have higher levels of vitamin D metabolites in the maternal and cord blood than the control group.
次要结局
未报告次要终点
研究者
Xinyin Jiang
Associate professor
City University of New York