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

Indonesia University56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

PreTerm Birth

Interventions

ZincDRUG

included in intervention arm

NifedipineDRUG

included in intervention and control arm

Beta CaroteneDRUG

included in intervention arm

Vitamin D3

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

placenta MyD88

Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

Time frame: 1 year

placenta TRIF

Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

Time frame: 1 year

Placenta NFkB

Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

Time frame: 1 year

Placenta 25(OH)D

Placenta 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

Time frame: 1 year

Placenta vitamin A

Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

Time frame: 1 year

Placenta zinc

Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)

Time frame: 1 year

Placenta IL-1B

Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)

Time frame: 1 year

Serum zinc

Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)

Time frame: 1 year

Data from ClinicalTrials.gov

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