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Идёт набор NCT07226414

Prenatal Study in Healthy Pregnant Women

Без фазы С лечением Pregnancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Prenatal Capsule, Prenatal Gummy.
Кому может быть актуально
Состояния в реестре: Pregnancy. Базовые параметры: 21 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.

Обзор

Clinical Trial Summary The goal of this clinical trial is to address the impact of a gummy prenatal vs a capsule based prenatal in pregnant women. The main question it aims to answer is: Does 12-week daily administration of Prenatal Capsule affect serum iron levels in pregnant women in their second trimester compared to a comparator gummy prenatal? Researchers will compare Prenatal Capsule to a comparator Prenatal Gummy to see if there are differences in serum iron levels after 12 weeks of daily use. Participants will: Take their assigned prenatal supplement (either Prenatal Capsule or the comparator Prenatal Gummy) daily for 12 weeks Be in their second trimester of pregnancy during the study period Have their serum iron levels measured at baseline and after the 12-week intervention period

Вмешательства

  • Пищевая добавка Prenatal Capsule
    This study will look at the impacts of a prenatal capsule vs a gummy comparator prenatal. The prenatal consists of 2 multivitamin + micronutrient blend with one omega softgel.
  • Пищевая добавка Prenatal Gummy
    This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA

Первичные конечные точки

  • Change from Baseline to end of intervention on iron levels [Срок оценки: 12 weeks]
Вторичные конечные точки (4)
  • Change from baseline to end of intervention on folate status [Срок оценки: 12 weeks]
  • Change from baseline to end of intervention on omega-3 status [Срок оценки: 12 weeks]
  • Change from baseline to end of intervention on serum Vitamin D [Срок оценки: 12 weeks]
  • Change from baseline to end of intervention on choline status [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Be able to give written informed consent.
  • Healthy pregnant women between 21- 40 years of age (inclusive).
  • Pregnant women in the second trimester of pregnancy (gestational age of 14-19 weeks).
  • Willing to consume the Study Product daily for the duration of the study.

Критерии исключения

  • History of drug or alcohol abuse
  • Is hypersensitive to any of the contents of the study product, that would preclude intake of the study products.
  • Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk, or would confound the interpretation of the study results as judged by the investigator on the basis of medical history.
  • Severe nausea and vomiting in the first trimester, including hyperemesis gravidarum (HG)
  • Inability to tolerate oral supplement intake due to gastrointestinal symptoms during the first trimester of pregnancy
  • Prior Pregnancy Complications (gestational diabetes (GD), HG, or pre-eclampsia, NTDs (Neural Tube Defects))
  • Current pregnancy complications (GD, Iron Deficiency Anemia)
  • Hypertension
  • Diabetes mellitus
  • Cardiovascular disease
  • Class II/III obesity (defined as BMI ≥35.0 Kg/m2)
  • Malabsorption syndromes (e.g., celiac disease, inflammatory bowel disease)
  • Severe anemia or iron overload disorders
  • Thyroid disorders
  • Current or recent (in the past 12 weeks prior to Visit 1) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, as judged by the investigator. Prohibited medications include:

Medications that contain fat-soluble vitamins A, E, or K in high doses

\- Current or recent (in the past 12 weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results as judged by the investigator.

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
  • Atlantia Clinical Trials, Chicago — Chicago

Идентификаторы

NCT: NCT07226414 · AFCRO-200

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗