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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06035315
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Rima Irwinda, Dr Cipto Mangunkusumo General Hospital

Study Description
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Brief Summary:
To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes

Condition or disease Intervention/treatment Phase
Maternal Care Patterns Nutrition, Healthy Nutritional Deficiency Maternal-Fetal Relations Perinatal Outcome Maternal Outcome Dietary Supplement: Multiple Micronutrients during pregnancy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial : comparison of two clusters
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Maternal Outcome [ Time Frame: 1 year ]
    Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage

  2. Perinatal Outcome [ Time Frame: 1 year ]
    Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035315


Contacts
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Contact: Yurika Elizabeth, Medical Doctor +62 8999979916 yurika.elizabeth.s@gmail.com
Contact: Amanda Rumondang, Obstetrician Gynecologist +62 81318375211 amanda17.md@gmail.com

Locations
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Indonesia
Cipto Mangunkusumo General Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Rima Irwinda, PhD    +62 812-9044-604    rima.irwinda@yahoo.com   
Contact: Amanda Rumondang, Obstetrician Gynecologist    +62 813 18375211    amanda17.md@gmail.com   
Cipto Mangunkusumo General Hospital Recruiting
Jakarta, Indonesia, 10430
Contact: Rima Irwinda, PhD    +62 812-9044-604    rima.irwinda@yahoo.com   
Contact: Amanda Rumondang, Obstetricians Gynecologist    +62 81318375211    amanda17.md@gmail.com   
Sponsors and Collaborators
Dr Cipto Mangunkusumo General Hospital
More Information
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Responsible Party: Rima Irwinda, MD, OBGYN, PhD, Dr Cipto Mangunkusumo General Hospital
ClinicalTrials.gov Identifier: NCT06035315    
Other Study ID Numbers: 23-02-0259
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Micronutrients
Trace Elements
Physiological Effects of Drugs