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

NCT06929793 | Active Not Recruiting

• 1 other identifier: 24081311
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Angiogenesis; Fetal Weight; Pregnancy Related; Nutrient Element Deficiency; High Risk Pregnancy

Keywords

micronutrients; angiogenesis; vasculogenesis; fetal biometry

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR

1. Multiple micronutrient 2. Calcium Carbonat 766 mg 3. Vitamin D3 5000 IU 4. DHA 300 mg

Dietary Supplement: Multiple Micronutrients

Control

PLACEBO COMPARATOR

Standard antenatal vitamins

Drug: Standard Antenatal Vitamin

Interventions

Multiple Micronutrients DIETARY_SUPPLEMENT

1. Multiple micronutrient 2. Calcium Carbonat 766 mg 3. Vitamin D3 5000 IU 4. DHA 300 mg

Intervention

Standard Antenatal Vitamin DRUG

Standard Antenatal Vitamin given in Community Health Centers

Control

Eligibility Criteria

• Gender Eligibility Details: Pregant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Fetal Weight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: March 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2024-08

Locations

ID (1)