Multiple Micronutrient Versus Iron-Folic Acid Supplementation in Pregnant Women in Indonesia

Effect of Multiple Micronutrient Supplementation Versus Iron and Folic Acid Supplementation on Maternal Nutritional Biomarkers and Birth Outcomes Among Pregnant Women in Indonesia

Micronutrient deficiencies during pregnancy may affect the mother's nutritional status and the baby's growth. This study compared two types of daily supplements for pregnant women: a multiple micronutrient supplement and an iron and folic acid supplement.

Pregnant women in Indonesia who were at 12 weeks of gestation or earlier were randomly assigned to receive one of the two supplements for eight weeks. The study measured maternal body weight, mid-upper arm circumference, hemoglobin concentration, and serum zinc concentration before and after supplementation. Infant birth weight and the occurrence of low birth weight were assessed after delivery.

The purpose of the study was to determine whether multiple micronutrient supplementation produced greater improvements in maternal nutritional indicators and birth outcomes than iron and folic acid supplementation.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Low Birth Weight; Maternal Anemia; Maternal Micronutrient Status
• Intervention / Treatment: Dietary supplement: Multiple micronutrient supplementation; Dietary supplement: Iron and Folic Acid Supplementation

Detailed Description

This study was designed as a randomized, double-blind, parallel-group trial comparing daily multiple micronutrient supplementation with daily iron and folic acid supplementation among pregnant women in Indonesia. Participants received the assigned supplement for eight weeks. Maternal anthropometric and biochemical indicators were assessed before and after the intervention, and birth outcomes were assessed after delivery.

This study was registered retrospectively because prospective registration was inadvertently omitted during study initiation. Information entered in this record was derived from the original study protocol and available study documentation.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Purwodadi Grobogan, Central Java, Indonesia, 90222
      • Puskesmas Grobogan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Pregnant women at 12 weeks of gestation or earlier Aged 18 to 40 years No diagnosed chronic disease Willing to complete all study procedures Provided written informed consent

Exclusion Criteria:

Severe pregnancy complications Known allergy to any supplement ingredient Inability to communicate adequately with the research team Planned relocation from the study area within the following six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Micronutrient Supplementation; Participants assigned to this arm received one multiple micronutrient supplement daily for eight weeks.	Dietary supplement: Multiple micronutrient supplementation; One tablet was administered orally once daily for eight weeks.; Other Names: MMS
Active Comparator: Iron and Folic Acid Supplementation; Participants assigned to this arm received one iron and folic acid supplement daily for eight weeks according to the applicable antenatal supplementation standard.	Dietary supplement: Iron and Folic Acid Supplementation; One tablet was administered orally once daily for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maternal Body Weight	Change in maternal body weight calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in kilograms.	Baseline and 8 weeks
Change in Maternal Mid-Upper Arm Circumference	Change in maternal mid-upper arm circumference calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in centimeters.	Baseline and 8 weeks
Change in Maternal Hemoglobin Concentration	Change in maternal hemoglobin concentration calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in g/dL. Time Frame:	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Indonesia Timur University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2025
• Primary Completion (Actual): December 25, 2025
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Low Birth Weight; Maternal Nutrition; Multiple Micronutrient Supplementation; Birth Weight; Maternal Hemoglobin; Iron and Folic Acid Supplementation
• Additional Relevant MeSH Terms: Body Weight; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Birth Weight; Inorganic Chemicals; Elements; Metals; Metals, Heavy; Transition Elements; Iron
• Other Study ID Numbers: 49/Kom.etik/VI/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the informed consent obtained from participants did not include permission for sharing individual-level data with external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No