AngiogenesisNCT06929793
Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry
A study testing Multiple Micronutrients and Standard Antenatal Vitamin in people with Angiogenesis and Fetal Weight, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Angiogenesis, Fetal Weight, Pregnancy Related
- What is being tested?
- Multiple Micronutrients and Standard Antenatal Vitamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2024to 30 Jun 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
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
- Being tested
- Multiple Micronutrients, Standard Antenatal Vitamin
- Keywords
- micronutrients, angiogenesis, vasculogenesis, fetal biometry
- Medical subject headings
- Fetal Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple MicronutrientsDietary supplement
- Multiple micronutrient
- Calcium Carbonat 766 mg
- Vitamin D3 5000 IU
- DHA 300 mg
Standard Antenatal VitaminDrug
Standard Antenatal Vitamin given in Community Health Centers
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 1. Multiple micronutrient
2. Calcium Carbonat 766 mg
3. Vitamin D3 5000 IU
4. DHA 300 mg Receives: Dietary Supplement: Multiple Micronutrients |
| Control | Placebo comparator | Standard antenatal vitamins Receives: Drug: Standard Antenatal Vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PlGF levels
Examination of angiogenesis factors in both research groups, using venous blood to measure Placental Growth Factor (PlGF) levels
Measured: 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),
Measured: 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
Measured: 1. Trimester 1 : 8-14 weeks. 2. Trimester 2 : 20-26 weeks.
Head circumference
Head circumference based on ultrasonography
Measured: 20-26 weeks of gestation
Femur length
Femur length based on ultrasonography
Measured: 20-26 weeks of gestation
Estimated fetal weight
Estimated fetal weight based on ultrasonography
Measured: 20-26 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Mar 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiogenesisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Rumondang, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929793
- Sponsor's protocol ID
- 24081311
- Status last verified
- Aug 2024
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry
- ClinicalTrials.gov ID
- NCT06929793
- Acronym / sponsor ID
- 24081311
- Conditions
- Angiogenesis, Fetal Weight, Pregnancy Related, Nutrient Element Deficiency, High Risk Pregnancy
- Keywords
- micronutrients, angiogenesis, vasculogenesis, fetal biometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Apr 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Multiple Micronutrients1. Multiple micronutrient 2. Calcium Carbonat 766 mg 3. Vitamin D3 5000 IU 4. DHA 300 mg |
| Control | Placebo comparator | Drug: Standard Antenatal VitaminStandard antenatal vitamins |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Multiple pregnancies.
- Pregnancy with assisted reproduction.
- History of polycystic ovary syndrome.
- History of chronic hypertension.
- History of gestational diabetes mellitus.
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 Micronutrients1. Multiple micronutrient 2. Calcium Carbonat 766 mg 3. Vitamin D3 5000 IU 4. DHA 300 mg | Dietary supplement | Intervention |
| Standard Antenatal VitaminStandard Antenatal Vitamin given in Community Health Centers | Drug | Control |
Primary outcome
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
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),
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
Head circumference
Time frame: 20-26 weeks of gestation
Head circumference based on ultrasonography
Femur length
Time frame: 20-26 weeks of gestation
Femur length based on ultrasonography
Estimated fetal weight
Time frame: 20-26 weeks of gestation
Estimated fetal weight based on ultrasonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 Micronutrients and Standard Antenatal Vitamin in people with Angiogenesis and Fetal Weight, run by Dr Cipto Mangunkusumo General Hospital 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
PlGF levels (time frame: It was carried out at gestational age: 1. Trimester 1: 8-14 weeks. 2. Trimester 2: 20-26 weeks.). The study lists 6 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 16 Apr 2025.