The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β
Primary Purpose
PreTerm Birth
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zinc
Nifedipine
Beta Carotene
Vitamin D3
Dexamethasone
Sponsored by

About this trial
This is an interventional basic science trial for PreTerm Birth
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Intervention
Control
Arm 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
Nifedipin 4x10 mg Dexamethasone 2x6 mg iv for 2 days
Outcomes
Primary Outcome Measures
placenta MyD88
Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
placenta TRIF
Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Placenta NFkB
Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
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)
Placenta vitamin A
Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
Placenta zinc
Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Placenta IL-1B
Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)
Serum zinc
Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Serum 25(OH)D
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
Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
Secondary Outcome Measures
Full Information
NCT ID
NCT03005496
First Posted
December 19, 2016
Last Updated
November 18, 2017
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT03005496
Brief Title
The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreTerm Birth
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Placebo Comparator
Arm 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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Nifedipin 4x10 mg
Dexamethasone 2x6 mg iv for 2 days
Intervention Type
Drug
Intervention Name(s)
Zinc
Other Intervention Name(s)
Zinc Picolinate 50 mg
Intervention Description
included in intervention arm
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Other Intervention Name(s)
Nifedipine 10 mg
Intervention Description
included in intervention and control arm
Intervention Type
Drug
Intervention Name(s)
Beta Carotene
Other Intervention Name(s)
Beta carotene 25,000 IU
Intervention Description
included in intervention arm
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol 50,000 IU
Intervention Description
included in intervention arm
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexamethasone 6 mg
Intervention Description
included in intervention and control arm
Primary Outcome Measure Information:
Title
placenta MyD88
Description
Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Time Frame
1 year
Title
placenta TRIF
Description
Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Time Frame
1 year
Title
Placenta NFkB
Description
Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Time Frame
1 year
Title
Placenta 25(OH)D
Description
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
Title
Placenta vitamin A
Description
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
Title
Placenta zinc
Description
Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Time Frame
1 year
Title
Placenta IL-1B
Description
Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)
Time Frame
1 year
Title
Serum zinc
Description
Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Time Frame
1 year
Title
Serum 25(OH)D
Description
Serum 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
Title
Serum vitamin A
Description
Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
Learn more about this trial
The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β
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