Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry

April 15, 2025 updated by: Amanda Rumondang, Dr Cipto Mangunkusumo General Hospital
Multiple micronutrients play an important role during pregnancy, since the decidualization and implantation phases. It has an impact on placentation and remodeling of blood vessels. The optimal early pregnancy conditions accompanied by great angiogenesis and vasculogenesis factors will influence fetal growth. This study aims to determine the effect of maternal multiple micronutrient supplementation on angiogenesis factors, vasculogenesis factors, and fetal biometry. It is a clustered randomized controlled trial that aims to determine the impact of maternal micronutrient supplementation on PlGF levels, sFlt-1/PlGF ratio, mean pulsatility index of uterine artery, and fetal biometry (head circumference, femur length, and estimated fetal weight percentile). The target population for the study was all pregnant women who underwent antenatal check-ups at community health centers in DKI Jakarta.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Pregnant women with gestation age 8 - 14 weeks.
  2. Singleton pregnancy.
  3. Living in DKI Jakarta.
  4. Can consume tablets or caplets.
  5. Willing to only consume the vitamins used in the research
  6. Willing to undergo antenatal examination at community health centers in DKI Jakarta.
  7. Willing to be a research subject by signing the research consent form.

Exclusion Criteria:

  1. Multiple pregnancies.
  2. Pregnancy with assisted reproduction.
  3. History of polycystic ovary syndrome.
  4. History of chronic hypertension.
  5. History of gestational diabetes mellitus.
  6. Diagnosed with type 2 diabetes mellitus.
  7. History of preeclampsia.
  8. Recurrent miscarriage (Recurrent Pregnancy Loss).
  9. Maternal medical conditions (Autoimmune; Heart Disease; Malignancy).
  10. History of chronic infection.
  11. Cannot consume tablets or caplets
  12. Planning to move out of DKI Jakarta before and/or not giving birth in DKI Jakarta.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention
  1. Multiple micronutrient
  2. Calcium Carbonat 766 mg
  3. Vitamin D3 5000 IU
  4. DHA 300 mg
Dietary supplement: Multiple Micronutrients
  1. Multiple micronutrient
  2. Calcium Carbonat 766 mg
  3. Vitamin D3 5000 IU
  4. DHA 300 mg
Placebo Comparator: Control
Standard antenatal vitamins
Drug: Standard Antenatal Vitamin
Standard Antenatal Vitamin given in Community Health Centers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PlGF levels
Time Frame: It was carried out at gestational age: 1. Trimester 1: 8-14 weeks. 2. Trimester 2: 20-26 weeks.
Examination of angiogenesis factors in both research groups, using venous blood to measure Placental Growth Factor (PlGF) levels
It was carried out at gestational age: 1. Trimester 1: 8-14 weeks. 2. Trimester 2: 20-26 weeks.
sFlt-1/PlGF ratio
Time Frame: 20-26 weeks of gestation
Examination of the balance of angiogenesis factors in both groups, using venous blood to measure the ratio of soluble fms-Like Tyrosine Kinase-1 to Placental Growth Factor (s-Flt-1/PlGF),
20-26 weeks of gestation
mean pulsatility index of uterine artery
Time Frame: 1. Trimester 1 : 8-14 weeks. 2. Trimester 2 : 20-26 weeks.
Examination of vasculogenesis factors by measuring the mean Pulsatility Index of bilateral uterine arteries
1. Trimester 1 : 8-14 weeks. 2. Trimester 2 : 20-26 weeks.
Head circumference
Time Frame: 20-26 weeks of gestation
Head circumference based on ultrasonography
20-26 weeks of gestation
Femur length
Time Frame: 20-26 weeks of gestation
Femur length based on ultrasonography
20-26 weeks of gestation
Estimated fetal weight
Time Frame: 20-26 weeks of gestation
Estimated fetal weight based on ultrasonography
20-26 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr Cipto Mangunkusumo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24081311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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