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

ConditionsMaternal Anemia Micronutrient Deficiency Pregnancy Outcomes Maternal Nutrition

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorSindh Institute of Child Health and Neonatology

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women aged 18 years or older

Gestational age ≤20 weeks at enrollment

Singleton pregnancy

Hemoglobin concentration ≥10 g/dL at baseline

Disqualifiers

Severe anemia requiring injectable treatment (hemoglobin <7 g/dL)

Pre-existing diabetes mellitus

Pre-existing hypertension

Renal disease

Trial design

Design model

Parallel

Treatments tested in this trial

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
Iron-Folic Acid (IFA)
Dietary supplement
Iron 60 mg and folic acid 400 µg administered daily during pregnancy.

Treatment groups

402 Participants

are divided into 3 treatment groups

Group A: MMSExperimental treatment 1 intervention

Group B: MMS + IFAExperimental treatment 2 interventions

Group C: IFAActive comparator 1 intervention

Trial outcomes

Primary outcomes

Maternal Hemoglobin Concentration

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

Time frame

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

Secondary outcomes

Birth Weight

Neonatal birth weight measured in grams within one hour of birth.

Time frame

At birth

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sindh Institute of Child Health and Neonatology

Lead sponsor

Source ClinicalTrials.gov

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