The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: PreTerm Birth

Treatments: Drug: Nifedipine; Drug: Zinc; Drug: Vitamin D3; Drug: Dexamethasone; Drug: Beta Carotene

Study type: Interventional

Funder types: Other

Identifiers

NCT03005496

50/UN.2F1/ETIK/2016

Details and patient eligibility

About

This study is a controlled trial which compares the effect of zinc, beta-carotene, and Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels in placenta.

Full description

The research will be held in Cipto Mangunkusumo General and Budi Kemuliaan Hospital.

Each participant of each group will be given the medication of preterm birth hospital protocol, which includes nifedipine 4x10 mg as tocolytic agent, dexamethasone 2x6 mg intravenous for 2 days which aims to support lung maturation, and antibiotic. Then, the blood sample is obtained for zinc, vitamin A and 25(OH)D levels examination. Subjects will be divided into 2 groups which are group whose given the oral zinc 50 mg/day, oral beta-carotene 25,000 IU and oral vitamin D3 50,000 IU/week supplementation, and group who is not given the intervention. Each participant will be observed until delivery. After delivery, level of zinc, vitamin A, and 25(OH)D in serum and placenta will be measured, as well as level of MyD88, TRIF, NFκB, and IL-1β in placenta.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women who has preterm birth in 26-36 weeks gestational age

Exclusion criteria

• Multiple pregnancy
• Drug allergy
• Intra Uterine Growth Retardation (IUGR) is detected
• Congenital malformation in fetus was found
• Preterm Premature Rupture of Membrane (PPROM)
• Maternal complication such as gestational hypertension, preeclampsia, gestational diabetes mellitus, heart disease, infection, and autoimmune disease

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups, including a placebo group

Intervention

Placebo Comparator group

Description:

* Nifedipin 4x10 mg oral * Dexamethasone 2x6 mg iv for 2 days * Zinc 50 mg/day * Beta-carotene 25,000 IU * Vitamin D3 50,000 IU/weekly

Treatment:

Drug: Beta Carotene

Drug: Dexamethasone

Drug: Vitamin D3

Drug: Zinc

Drug: Nifedipine

Control

Active Comparator group

Description:

* Nifedipin 4x10 mg * Dexamethasone 2x6 mg iv for 2 days

Treatment:

Drug: Dexamethasone

Drug: Nifedipine