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Completed

NCT Number: NCT03005496

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc

Drug

included in intervention arm

Other names: Zinc Picolinate 50 mg

nifedipine

Drug

included in intervention and control arm

Other names: Nifedipine 10 mg

Beta Carotene

Drug

included in intervention arm

Other names: Beta carotene 25,000 IU

Vitamin D3

Drug

included in intervention arm

Other names: Cholecalciferol 50,000 IU

Dexamethasone

Drug

included in intervention and control arm

Other names: Dexamethasone 6 mg

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2016
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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