Perelel Prenatal Supplements vs. Generic Prenatal Supplements and Health of Mother and Baby (SUPPORT)

Официальное название

Impact of Perelel Trimester-Specific Dietary Supplements vs. Generic Prenatal Supplements on Maternal and Fetal Health Outcomes: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Пищевая добавка Perelel Prenatal Vitamin
  Daily Perelel prenatal vitamin supplement throughout pregnancy
• Пищевая добавка Generic Prenatal Vitamin
  Daily generic prenatal vitamin supplement throughout pregnancy.

Первичные конечные точки

• Marker of Maternal Vitamin D Nutritional Status [Срок оценки: Through study completion, an average of 30 weeks]
• Marker of Maternal Total Folate (RBC) Nutritional Status [Срок оценки: Through study completion, an average of 30 weeks]
• Marker of Maternal Total Folate (Serum) Nutritional Status [Срок оценки: Through study completion, an average of 30 weeks]
• Marker of Maternal Serum Ferritin Nutritional Status [Срок оценки: Through study completion, an average of 30 weeks]
• Marker of Maternal Serum Vitamin B12 Nutritional Status [Срок оценки: Through study completion, an average of 30 weeks]
• Marker of Maternal Homocysteine Nutritional Status [Срок оценки: Through study completion, an average of 30 weeks]
• Marker of Maternal Folate Metabolites Nutritional Status [Срок оценки: Through study completion, an average of 30 weeks]

Вторичные конечные точки (9)

• Symptoms of Nausea and Vomiting in Pregnancy [Срок оценки: Through study completion, an average of 30 weeks]
• Symptoms of Depression in Pregnancy [Срок оценки: Through study completion, an average of 30 weeks]
• Symptoms of Anxiety in Pregnancy [Срок оценки: Through study completion, an average of 30 weeks]
• Symptoms of Stress in Pregnancy [Срок оценки: Through study completion, an average of 30 weeks]
• Sleep Quality in Pregnancy [Срок оценки: Through study completion, an average of 30 weeks]
• General Maternal Wellness in Third Trimester [Срок оценки: Through study completion, an average of 30 weeks]
• Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy [Срок оценки: Through study completion, an average of 30 weeks]
• Muscle Cramping Symptoms - Severity [Срок оценки: Through study completion, an average of 30 weeks]
• Muscle Cramping Symptoms - Frequency [Срок оценки: Through study completion, an average of 30 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• UPMC Magee-Womens Hospital — Pittsburgh

Идентификаторы

NCT: NCT07046845 · STUDY25020013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗