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

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: Active, not recruiting
• Conditions: Pregnancy Related; Angiogenesis; High Risk Pregnancy; Fetal Weight; Nutrient Element Deficiency
• Intervention / Treatment: Dietary supplement: Multiple Micronutrients; Drug: Standard Antenatal Vitamin

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Multiple micronutrient; Calcium Carbonat 766 mg; Vitamin D3 5000 IU; DHA 300 mg	Dietary supplement: Multiple Micronutrients; Multiple micronutrient; Calcium Carbonat 766 mg; Vitamin D3 5000 IU; 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

Outcome Measure	Measure Description	Time Frame
PlGF levels	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	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	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	Head circumference based on ultrasonography	20-26 weeks of gestation
Femur length	Femur length based on ultrasonography	20-26 weeks of gestation
Estimated fetal weight	Estimated fetal weight based on ultrasonography	20-26 weeks of gestation

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: micronutrients; angiogenesis; vasculogenesis; fetal biometry
• Additional Relevant MeSH Terms: Body Weight; Fetal Weight; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID 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