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Идёт набор NCT06079918

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

Фаза III С лечением Pregnancy Related

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: Multiple Micronutrient Supplements with 30 mg of elemental iron, Multiple Micronutrient Supplements with 45 mg of elemental iron, Multiple Micronutrient Supplements with 60 mg of elemental iron.
Кому может быть актуально
Состояния в реестре: Pregnancy Related. Базовые параметры: от 18 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
Tanzania
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

Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia

Обзор

This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.

Вмешательства

  • Пищевая добавка Multiple Micronutrient Supplements with 30 mg of elemental iron
    MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization until delivery.
  • Пищевая добавка Multiple Micronutrient Supplements with 45 mg of elemental iron
    MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.
  • Пищевая добавка Multiple Micronutrient Supplements with 60 mg of elemental iron
    MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.

Первичные конечные точки

  • Proportion of pregnant women with third-trimester moderate or severe anemia [Срок оценки: 3rd trimester (weeks 28-42 of pregnancy)]
Вторичные конечные точки (12)
  • Maternal hemoglobin concentration [Срок оценки: 3rd trimester (weeks 28-42 of pregnancy)]
  • Maternal hemoglobin concentration [Срок оценки: 6 weeks postpartum]
  • Proportion of pregnant women with anemia [Срок оценки: 3rd trimester (weeks 28-42 of pregnancy)]
  • Proportion of postpartum women with anemia [Срок оценки: 6 weeks postpartum]
  • Maternal serum ferritin [Срок оценки: 3rd trimester (weeks 28-42 of pregnancy)]
  • Proportion of pregnant women with iron deficiency [Срок оценки: 3rd trimester (weeks 28-42 of pregnancy)]
  • Proportion of pregnant women with iron deficiency anemia [Срок оценки: 3rd trimester (weeks 28-42 of pregnancy)]
  • Proportion of women with preeclampsia [Срок оценки: From 20 weeks gestation through delivery]
  • Proportion of women with antepartum bleeding [Срок оценки: From 24 weeks gestation through delivery]
  • Proportion of women with postpartum hemorrhage [Срок оценки: From delivery through 42 days post delivery]
  • Proportion of women with infection-related severe maternal outcomes [Срок оценки: During pregnancy through 42 days postpartum]
  • Proportion of women with pregnancy-related death [Срок оценки: Pregnancy through 42 days of pregnancy termination]

Критерии участия

Критерии включения

  • Attending first ANC visit at study clinics
  • Pregnant women < 20 weeks gestation by last menstrual period (LMP)
  • Aged ≥ 18 years old
  • Intending to stay in Dar es Salaam until 6 weeks post delivery
  • Provides informed consent

Критерии исключения

  • Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
  • Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
  • Concurrently enrolled in another nutritional clinical trial
  • Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Tanzania · 1 центр
  • Muhimbili University of Health and Allied Sciences — Dar es Salaam

Публикации

  • Smith ER, Muhihi A, Wylie BJ, Mugusi S, Aboud S, Bakari M, Fawzi W, Kinyogoli S, Oakley EM, Pan Q, Sando MM, Brownlee VS, Pembe AB, Sudfeld CR, Masanja H. Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy. Trials. 20 PMID 40517226

Идентификаторы

NCT: NCT06079918 · MMS-MAP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗