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The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β

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ClinicalTrials.gov Identifier: NCT03005496
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Rima Irwinda, 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.

Condition or disease Intervention/treatment Phase
PreTerm Birth Drug: Zinc Drug: Nifedipine Drug: Beta Carotene Drug: Vitamin D3 Drug: Dexamethasone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : January 2017
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Placebo Comparator: 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
Drug: Zinc
included in intervention arm
Other Name: Zinc Picolinate 50 mg

Drug: Nifedipine
included in intervention and control arm
Other Name: Nifedipine 10 mg

Drug: Beta Carotene
included in intervention arm
Other Name: Beta carotene 25,000 IU

Drug: Vitamin D3
included in intervention arm
Other Name: Cholecalciferol 50,000 IU

Drug: Dexamethasone
included in intervention and control arm
Other Name: Dexamethasone 6 mg

Active Comparator: Control
  • Nifedipin 4x10 mg
  • Dexamethasone 2x6 mg iv for 2 days
Drug: Nifedipine
included in intervention and control arm
Other Name: Nifedipine 10 mg

Drug: Dexamethasone
included in intervention and control arm
Other Name: Dexamethasone 6 mg




Primary Outcome Measures :
  1. placenta MyD88 [ Time Frame: 1 year ]
    Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

  2. placenta TRIF [ Time Frame: 1 year ]
    Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

  3. Placenta NFkB [ Time Frame: 1 year ]
    Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

  4. Placenta 25(OH)D [ Time Frame: 1 year ]
    Placenta 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

  5. Placenta vitamin A [ Time Frame: 1 year ]
    Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

  6. Placenta zinc [ Time Frame: 1 year ]
    Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)

  7. Placenta IL-1B [ Time Frame: 1 year ]
    Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)

  8. Serum zinc [ Time Frame: 1 year ]
    Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)

  9. Serum 25(OH)D [ Time Frame: 1 year ]
    Serum 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

  10. Serum vitamin A [ Time Frame: 1 year ]
    Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Rima Irwinda, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT03005496     History of Changes
Other Study ID Numbers: 50/UN.2F1/ETIK/2016
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Beta Carotene
Zinc
Dexamethasone
Dexamethasone acetate
Nifedipine
BB 1101
Carotenoids
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors