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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
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for PreTerm Birth

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    December 19, 2016
    Last Updated
    November 18, 2017
    Sponsor
    Indonesia University
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    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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