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

NCT07725549 | Completed

• 1 other identifier: 49/Kom.etik/VI/2025
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal Micronutrient Status; Pregnancy; Low Birth Weight; Maternal Anemia

Keywords

Multiple Micronutrient Supplementation; Iron and Folic Acid Supplementation; Maternal Nutrition; Maternal Hemoglobin; Birth Weight; Low Birth Weight

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Multiple Micronutrient Supplementation

EXPERIMENTAL

Participants assigned to this arm received one multiple micronutrient supplement daily for eight weeks.

Dietary Supplement: Multiple micronutrient supplementation

Iron and Folic Acid Supplementation

ACTIVE COMPARATOR

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

Interventions

Iron and Folic Acid Supplementation DIETARY_SUPPLEMENT

One tablet was administered orally once daily for eight weeks.

Iron and Folic Acid Supplementation

Multiple micronutrient supplementation DIETARY_SUPPLEMENT

One tablet was administered orally once daily for eight weeks.

Also known as: MMS

Multiple Micronutrient Supplementation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia Timur University: lead

Study Sites (1)

Puskesmas Grobogan

Purwodadi Grobogan, Central Java, 90222, Indonesia

Location

MeSH Terms

Conditions

Birth Weight

Interventions

Iron

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Principal Investigator

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups: multiple micronutrient supplementation or iron and folic acid supplementation. Each participant received the assigned supplement daily for eight weeks and remained in the same intervention group throughout the study.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 10, 2025
• Primary Completion: December 25, 2025
• Study Completion: April 10, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)