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

Sponsor

Dr Cipto Mangunkusumo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06035315

Collaborator

(none)

240

Enrollment

Locations

Arms

Anticipated Duration (Months)

120

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control trial : comparison of two clustersRandomized 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

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

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)

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

Outcome Measures

Primary Outcome Measures

Maternal Outcome [1 year]
Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
Perinatal Outcome [1 year]
Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430
2	Cipto Mangunkusumo General Hospital	Jakarta		Indonesia	10430

Sponsors and Collaborators

Dr Cipto Mangunkusumo General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Malnutrition

Micronutrients

Trace Elements

Study Results

No Results Posted as of Sep 13, 2023