MMS, IFA, and MMS+IFA Supplementation in Pregnant Women
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
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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sher Wali Khan, MS
- Número de telefone: +923452860165
- E-mail: khansiut1@yahoo.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: MMS
Multiple Micronutrient Supplementation (MMS) containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy.
|
WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy
|
|
Experimental: MMS + IFA
Combined Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA) supplementation administered daily during pregnancy.
Total iron and folic acid intake will remain within safe WHO-recommended limits
|
WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy
Iron 60 mg and folic acid 400 µg administered daily during pregnancy.
|
|
Comparador Ativo: IFA
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Iron 60 mg and folic acid 400 µg administered daily during pregnancy.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maternal Hemoglobin Concentration
Prazo: Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery
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Maternal hemoglobin concentration measured using complete blood count (CBC) and compared between study groups.
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Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Birth Weight
Prazo: At birth
|
Neonatal birth weight measured in grams within one hour of birth.
|
At birth
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rozina Feroz Ali, MBBS, MSC, Sindh Institute of Child Health and Neonatology
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- SICHN/IRB-011/2026
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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