Maternal Micronutrient StatusNCT07725549
Multiple Micronutrient Versus Iron-Folic Acid Supplementation in Pregnant Women in Indonesia
A study testing Multiple micronutrient supplementation and Iron and Folic Acid Supplementation in people with Maternal Micronutrient Status and Pregnancy, run by Indonesia Timur University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Maternal Micronutrient Status, Pregnancy, Low Birth Weight
- What is being tested?
- Multiple micronutrient supplementation and Iron and Folic Acid Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jul 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Multiple micronutrient supplementation, Iron and Folic Acid Supplementation
- Keywords
- Multiple Micronutrient Supplementation, Iron and Folic Acid Supplementation, Maternal Nutrition, Maternal Hemoglobin, Birth Weight, Low Birth Weight
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient supplementationDietary supplement
Also called MMS
One tablet was administered orally once daily for eight weeks.
Iron and Folic Acid SupplementationDietary supplement
One tablet was administered orally once daily for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Micronutrient Supplementation | Experimental | Participants assigned to this arm received one multiple micronutrient supplement daily for eight weeks. Receives: 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. Receives: Dietary Supplement: Iron and Folic Acid Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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:
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start10 Jul 2025
- Primary completion25 Dec 2025
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Micronutrient StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indonesia Timur University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rosdiana Syakur, Indonesia Timur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725549
- Sponsor's protocol ID
- 49/Kom.etik/VI/2025
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multiple Micronutrient Supplementation Versus Iron and Folic Acid Supplementation on Maternal Nutritional Biomarkers and Birth Outcomes Among Pregnant Women in Indonesia
- ClinicalTrials.gov ID
- NCT07725549
- Acronym / sponsor ID
- 49/Kom.etik/VI/2025
- Keywords
- Multiple Micronutrient Supplementation, Iron and Folic Acid Supplementation, Maternal Nutrition, Maternal Hemoglobin, Birth Weight, Low Birth Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Indonesia Timur UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multiple Micronutrient Supplementation | Experimental | Dietary Supplement: Multiple micronutrient supplementationParticipants assigned to this arm received one multiple micronutrient supplement daily for eight weeks. |
| Iron and Folic Acid Supplementation | Active comparator | Dietary Supplement: Iron and Folic Acid SupplementationParticipants assigned to this arm received one iron and folic acid supplement daily for eight weeks according to the applicable antenatal supplementation standard. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple micronutrient supplementationAlso: MMSOne tablet was administered orally once daily for eight weeks. | Dietary supplement | Multiple Micronutrient Supplementation |
| Iron and Folic Acid SupplementationOne tablet was administered orally once daily for eight weeks. | Dietary supplement | Iron and Folic Acid Supplementation |
Primary outcome
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.
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.
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:
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple micronutrient supplementation and Iron and Folic Acid Supplementation in people with Maternal Micronutrient Status and Pregnancy, run by Indonesia Timur University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal Body Weight (time frame: Baseline and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.