The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β
NCT ID: NCT03005496
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2017-01-31
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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
Zinc
included in intervention arm
Nifedipine
included in intervention and control arm
Beta Carotene
included in intervention arm
Vitamin D3
included in intervention arm
Dexamethasone
included in intervention and control arm
Control
* Nifedipin 4x10 mg
* Dexamethasone 2x6 mg iv for 2 days
Nifedipine
included in intervention and control arm
Dexamethasone
included in intervention and control arm
Interventions
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Zinc
included in intervention arm
Nifedipine
included in intervention and control arm
Beta Carotene
included in intervention arm
Vitamin D3
included in intervention arm
Dexamethasone
included in intervention and control arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Rima Irwinda
MD
Other Identifiers
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50/UN.2F1/ETIK/2016
Identifier Type: -
Identifier Source: org_study_id