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

Dr Cipto Mangunkusumo General Hospital

Status: Enrolling

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

Treatments: Dietary Supplement: Multiple Micronutrients during pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT06035315

23-02-0259

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Interventions

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Multiple Micronutrients during pregnancy