The Effect of Zinc, Beta-carotene, and Vitamin D3 Supplementation as Pro-inflammation Mediated Regulator in Preterm Delivery Through Placental Protein Adaptor MyD88 and TRIF, Transcription Factor NFkB, and Pro-inflammatory Cytokine IL-1β
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- placenta MyD88
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who has preterm birth in 26-36 weeks gestational age
排除标准
- •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
研究组 & 干预措施
Intervention
- 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
干预措施: Zinc (Drug)
Intervention
- 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
干预措施: Nifedipine (Drug)
Intervention
- 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
干预措施: Beta Carotene (Drug)
Intervention
- 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
干预措施: Vitamin D3 (Drug)
Intervention
- 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
干预措施: Dexamethasone (Drug)
Control
- Nifedipin 4x10 mg
- Dexamethasone 2x6 mg iv for 2 days
干预措施: Nifedipine (Drug)
Control
- Nifedipin 4x10 mg
- Dexamethasone 2x6 mg iv for 2 days
干预措施: Dexamethasone (Drug)
结局指标
主要结局
placenta MyD88
时间窗: 1 year
Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
placenta TRIF
时间窗: 1 year
Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Placenta NFkB
时间窗: 1 year
Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Placenta 25(OH)D
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 1 year
Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)
Serum zinc
时间窗: 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
时间窗: 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
时间窗: 1 year
Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
次要结局
未报告次要终点