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

September 6, 2023 updated by: Rima Irwinda, Dr Cipto Mangunkusumo General Hospital
To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Amanda Rumondang, Obstetrician Gynecologist
  • Phone Number: +62 81318375211
  • Email: amanda17.md@gmail.com

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo General Hospital
        • Contact:
        • Contact:
          • Amanda Rumondang, Obstetricians Gynecologist
          • Phone Number: +62 81318375211
          • Email: amanda17.md@gmail.com
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo General Hospital
        • Contact:
        • Contact:
          • Amanda Rumondang, Obstetrician Gynecologist
          • Phone Number: +62 813 18375211
          • Email: amanda17.md@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: 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)
Dietary supplement: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Outcome
Time Frame: 1 year
Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
1 year
Perinatal Outcome
Time Frame: 1 year
Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-02-0259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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