Impact of Perelel Trimester-Specific Dietary Supplements vs. Generic Prenatal Supplements on Maternal and Fetal Health Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Marker of Maternal Total Folate (RBC) Nutritional Status
研究概览
简要总结
The goal of this clinical trial is to learn if using Perelel-brand prenatal supplements versus a generic prenatal supplement improves the health of the mother and fetus (unborn baby) during pregnancy.
The main question it aims to answer is:
• How does taking Perelel prenatal supplements versus generic prenatal supplements during pregnancy change the nutritional markers in blood samples?
Participants will:
- Take either Perelel or generic prenatal supplements daily throughout pregnancy
- Visit UPMC Magee-Womens Hospital once every trimester of pregnancy for blood draws and answering questionnaires
In an observational part of this study for different participants, researchers will use blood tests and questionnaires only once during the first trimester to compare pregnant women without food insecurity to those with food insecurity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant with only one baby
- •Identify as having food insecurity
- •Receiving care at a Magee-Womens Hospital associated prenatal practice
- •Less than 12 weeks' of pregnancy
排除标准
- •Currently using prenatal supplement(s)
- •Unborn baby (fetus) identified as having a chromosomal or structural defect
- •Have a condition that prevents absorption of nutrients from food
- •History of medically treated thyroid disorder
- •Ongoing steroid use
研究组 & 干预措施
Perelel Prenatal Supplement Group
干预措施: Perelel Prenatal Vitamin (Dietary Supplement)
Generic Prenatal Supplement Group
干预措施: Generic Prenatal Vitamin (Dietary Supplement)
Observational Arm
结局指标
主要结局
Marker of Maternal Total Folate (RBC) Nutritional Status
时间窗: Through study completion, an average of 30 weeks
Assay of Total Folate (RBC) in Blood Samples
Marker of Maternal Total Folate (Serum) Nutritional Status
时间窗: Through study completion, an average of 30 weeks
Assay of Total Folate (Serum) in Blood Samples
Marker of Maternal Serum Ferritin Nutritional Status
时间窗: Through study completion, an average of 30 weeks
Assay of Serum Ferritin in Blood Samples
Marker of Maternal Homocysteine Nutritional Status
时间窗: Through study completion, an average of 30 weeks
Assay of Homocysteine in Blood Samples
Marker of Maternal Folate Metabolites Nutritional Status
时间窗: Through study completion, an average of 30 weeks
Assay of Folate Metabolites in Blood Samples
Marker of Maternal Vitamin D Nutritional Status
时间窗: Through study completion, an average of 30 weeks
Assay of Serum 25-hydroxyvitamin D3 in Blood Samples
Marker of Maternal Serum Vitamin B12 Nutritional Status
时间窗: Through study completion, an average of 30 weeks
Assay of Serum Vitamin B12 in Blood Samples
次要结局
- Symptoms of Nausea and Vomiting in Pregnancy(Through study completion, an average of 30 weeks)
- Symptoms of Depression in Pregnancy(Through study completion, an average of 30 weeks)
- Symptoms of Anxiety in Pregnancy(Through study completion, an average of 30 weeks)
- Symptoms of Stress in Pregnancy(Through study completion, an average of 30 weeks)
- Sleep Quality in Pregnancy(Through study completion, an average of 30 weeks)
- General Maternal Wellness in Third Trimester(Through study completion, an average of 30 weeks)
- Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy(Through study completion, an average of 30 weeks)
- Muscle Cramping Symptoms - Severity(Through study completion, an average of 30 weeks)
- Muscle Cramping Symptoms - Frequency(Through study completion, an average of 30 weeks)
研究者
Hyagriv Simhan
Professor & Executive Vice Chair, OB/GYN/RS, Director, Clinical Innovation in Women's Health, UPMC
University of Pittsburgh