The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes

NCT ID: NCT06035315

Last Updated: 2023-09-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-08-31

Brief Summary

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To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes

Detailed Description

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A randomized control trial of two clusters :

1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.

Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.

In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations.

Ultrasound examination was performed for both cluster since 1st until 3rd trimester.

Conditions

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Maternal Care Patterns Nutrition, Healthy Nutritional Deficiency Maternal-Fetal Relations Perinatal Outcome Maternal Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial : comparison of two clusters
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Pregnant women examine since 8 weeks gestation are being followed until delivery; are given government micronutrients; and perform ultrasound examinations each trimester and regular laboratory examination.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)

Group Type ACTIVE_COMPARATOR

Multiple Micronutrients during pregnancy

Intervention Type DIETARY_SUPPLEMENT

Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)

Interventions

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Multiple Micronutrients during pregnancy

Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* First trimester pregnancy
* Gestational age \< 10 weeks gestation
* Agree as research participant
* Living in DKI Jakarta

Exclusion Criteria

* Assisted Reproductive
* History of PCOS
* History of Chronic Hypertension
* History of Diabetes Mellitus
* History of Preeclampsia
* Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy)
* Plan to move from Jakarta prior or during pregnancy
* History of Recurrent pregnancy loss
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rima Irwinda

MD, OBGYN, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Cipto Mangunkusumo General Hospital

Jakarta, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Yurika Elizabeth, Medical Doctor

Role: CONTACT

+62 8999979916

Amanda Rumondang, Obstetrician Gynecologist

Role: CONTACT

+62 81318375211

Facility Contacts

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Rima Irwinda, PhD

Role: primary

+62 812-9044-604

Amanda Rumondang, Obstetrician Gynecologist

Role: backup

+62 813 18375211

Rima Irwinda, PhD

Role: primary

+62 812-9044-604

Amanda Rumondang, Obstetricians Gynecologist

Role: backup

+62 81318375211

Other Identifiers

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23-02-0259

Identifier Type: -

Identifier Source: org_study_id

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