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

Nutrition, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035315
• Other study ID #: 23-02-0259
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: Yurika Elizabeth, Medical Doctor
• Phone: +62 8999979916
• Email: yurika.elizabeth.s[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Maternal Care Patterns
• Maternal Outcome
• Maternal-Fetal Relations
• Nutritional Deficiency
• Perinatal Outcome

Intervention

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)

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

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