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Completed

NCT Number: NCT07725549

Multiple Micronutrient Versus Iron-Folic Acid Supplementation in 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.

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Key information

Conditions

Maternal Micronutrient Status Birth Weight Body Weight Low Birth Weight Maternal Anemia Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas Grobogan

Purwodadi Grobogan, Central Java, 90222, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple micronutrient supplementation

Dietary Supplement

One tablet was administered orally once daily for eight weeks.

Other names: MMS

Iron and Folic Acid Supplementation

Dietary Supplement

One tablet was administered orally once daily for eight weeks.

Primary outcomes

  1. Change in Maternal Body Weight

    Time frame: Baseline and 8 weeks

    Change in maternal body weight calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in kilograms.

  2. Change in Maternal Mid-Upper Arm Circumference

    Time frame: Baseline and 8 weeks

    Change in maternal mid-upper arm circumference calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in centimeters.

  3. Change in Maternal Hemoglobin Concentration

    Time frame: Baseline and 8 weeks

    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:

Sponsors and collaborators

Lead sponsor

Indonesia Timur University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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