The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β
- Conditions
- PreTerm Birth
- Interventions
- Registration Number
- NCT03005496
- Lead Sponsor
- Indonesia University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
- Pregnant women who has preterm birth in 26-36 weeks gestational age
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Zinc * 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 Intervention Vitamin D3 * 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 Intervention Beta Carotene * 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 Intervention Nifedipine * 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 Intervention Dexamethasone * 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 Control Nifedipine * Nifedipin 4x10 mg * Dexamethasone 2x6 mg iv for 2 days Control Dexamethasone * Nifedipin 4x10 mg * Dexamethasone 2x6 mg iv for 2 days
- Primary Outcome Measures
Name Time Method placenta MyD88 1 year Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
placenta TRIF 1 year Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Placenta NFkB 1 year Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Placenta 25(OH)D 1 year Placenta 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
Placenta vitamin A 1 year Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
Placenta zinc 1 year Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Placenta IL-1B 1 year Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)
Serum zinc 1 year Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Serum 25(OH)D 1 year Serum 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
Serum vitamin A 1 year Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
- Secondary Outcome Measures
Name Time Method