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

NCT07665957 | Not Yet Recruiting DMC

• 1 other identifier: SICHN/IRB-011/2026
• Study Type: interventional
• Target: 402
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Maternal Anemia; Micronutrient Deficiency; Pregnancy Outcomes; Maternal Nutrition

Keywords

Multiple Micronutrient Supplementation; MMS; Iron Folic Acid; IFA; Pregnancy; Maternal Anemia; Maternal Hemoglobin; Maternal Nutrition

Outcome Measures

Primary Outcomes (1)

• Maternal Hemoglobin Concentration

  Maternal hemoglobin concentration measured using complete blood count (CBC) and compared between study groups.

  Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery

Secondary Outcomes (1)

• Birth Weight

  At birth

Study Arms (3)

MMS

EXPERIMENTAL

Multiple Micronutrient Supplementation (MMS) containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy.

Dietary Supplement: Multiple Micronutrient Supplementation (MMS)

MMS + IFA

EXPERIMENTAL

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

Dietary Supplement: Multiple Micronutrient Supplementation (MMS); Dietary Supplement: Iron-Folic Acid (IFA)

IFA

ACTIVE COMPARATOR

Dietary Supplement: Iron-Folic Acid (IFA)

Interventions

Iron-Folic Acid (IFA) DIETARY_SUPPLEMENT

Iron 60 mg and folic acid 400 µg administered daily during pregnancy.

IFA; MMS + IFA

Multiple Micronutrient Supplementation (MMS) DIETARY_SUPPLEMENT

WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy

MMS; MMS + IFA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sindh Institute of Child Health and Neonatology: lead

Study Officials

• Rozina Feroz Ali, MBBS, MSC

  Sindh Institute of Child Health and Neonatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sher Wali Khan, MS

CONTACT

+923452860165; khansiut1@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Specialist

Model Details: Participants will be randomized in a 1:1:1 ratio to one of three parallel study arms: Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid supplementation (IFA), or combined MMS+IFA supplementation. Participants will remain in their assigned intervention group throughout the study period until delivery.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 25, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06