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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Angiogenesis Fetal Weight Pregnancy Related Nutrient Element Deficiency High Risk Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

Multiple Micronutrients

Intervention Type DIETARY_SUPPLEMENT

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

Control

Standard antenatal vitamins

Group Type PLACEBO_COMPARATOR

Standard Antenatal Vitamin

Intervention Type DRUG

Standard Antenatal Vitamin given in Community Health Centers

Interventions

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Multiple Micronutrients

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

Intervention Type DIETARY_SUPPLEMENT

Standard Antenatal Vitamin

Standard Antenatal Vitamin given in Community Health Centers

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes