MMS, IFA, and MMS+IFA Supplementation in Pregnant Women

Официальное название

Comparative Effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA), and Combined MMS+IFA on Maternal Hemoglobin Levels and Neonatal Outcomes Among Pregnant Women: An Open-Label Randomized Controlled Trial

Обзор

This study aims to compare the effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA) supplementation, and combined MMS+IFA supplementation among pregnant women. Maternal anemia and micronutrient deficiencies are common during pregnancy and can adversely affect both maternal and neonatal health outcomes. A total of 402 pregnant women with gestational age of 20 weeks or less will be randomly assigned to receive MMS, IFA, or combined MMS+IFA supplementation. Participants will be followed throughout pregnancy until delivery. Maternal hemoglobin levels, maternal compliance with supplementation, and neonatal outcomes including birth weight, preterm birth, APGAR scores, and congenital anomalies will be assessed. The findings of this study will provide evidence to guide antenatal nutrition policies and practices in Pakistan.

Подробное описание

Maternal micronutrient deficiencies remain a major public health concern in low- and middle-income countries, including Pakistan. Iron deficiency anemia, along with deficiencies of folate, vitamin D, vitamin B12, zinc, iodine, and other micronutrients, contributes substantially to adverse maternal and neonatal outcomes. Although routine Iron-Folic Acid (IFA) supplementation is recommended during pregnancy, it may not adequately address the broader spectrum of micronutrient deficiencies commonly observed among pregnant women.

Multiple Micronutrient Supplementation (MMS) has emerged as a comprehensive alternative that includes iron, folic acid, and additional essential vitamins and minerals required during pregnancy. Evidence from randomized controlled trials and systematic reviews suggests that MMS may improve selected neonatal outcomes; however, evidence regarding maternal hemoglobin improvement and compliance remains inconsistent across settings. Furthermore, limited data are available from Pakistan comparing MMS, IFA, and combined MMS+IFA supplementation.

This study is a three-arm, parallel-group, open-label randomized controlled trial conducted at the antenatal clinics of the Sindh Institute of Child Health and Neonatology (SICHN) in Karachi and Jamshoro, Pakistan. A total of 402 eligible pregnant women with gestational age ≤20 weeks and baseline hemoglobin ≥10 g/dL will be enrolled and randomized in a 1:1:1 ratio to receive either MMS, IFA, or combined MMS+IFA supplementation.

Maternal hemoglobin concentration will be measured at baseline, 28 weeks gestation, and 36-37 weeks gestation or delivery. Maternal compliance will be assessed using pill counts and self-reported supplement intake. Neonatal outcomes including birth weight, low birth weight, preterm birth, APGAR scores, and congenital anomalies will be evaluated at delivery.

The study aims to compare the effectiveness of MMS, IFA, and MMS+IFA supplementation on maternal hemoglobin levels, neonatal outcomes, and maternal compliance. Findings from this study will contribute to strengthening evidence-based antenatal nutrition policies and maternal health programs in Pakistan.

Вмешательства

• Пищевая добавка Multiple Micronutrient Supplementation (MMS)
  WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy
• Пищевая добавка Iron-Folic Acid (IFA)
  Iron 60 mg and folic acid 400 µg administered daily during pregnancy.

Первичные конечные точки

• Maternal Hemoglobin Concentration [Срок оценки: Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery]

Вторичные конечные точки (1)

• Birth Weight [Срок оценки: At birth]

Критерии участия

Критерии включения

• Pregnant women aged 18 years or older
• Gestational age ≤20 weeks at enrollment
• Singleton pregnancy
• Hemoglobin concentration ≥10 g/dL at baseline
• Willing and able to provide informed consent
• Willing to comply with study procedures and follow-up visits

Критерии исключения

• Severe anemia requiring injectable treatment (hemoglobin <7 g/dL)
• Pre-existing diabetes mellitus
• Pre-existing hypertension
• Renal disease
• Current therapeutic iron or micronutrient supplementation beyond routine antenatal supplementation
• Known fetal congenital anomalies
• Any medical condition that, in the opinion of the investigator, would interfere with study participation or outcome assessment

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

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07665957 · SICHN/IRB-011/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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