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

NCT03005496 | Completed Phase 4 DMC

• 1 other identifier: 50/UN.2F1/ETIK/2016
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PreTerm Birth

Outcome Measures

Primary Outcomes (10)

• placenta MyD88

  Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

  1 year

• placenta TRIF

  Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

  1 year

• Placenta NFkB

  Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)

  1 year

• 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)

  1 year

• Placenta vitamin A

  Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

  1 year

• Placenta zinc

  Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)

  1 year

• Placenta IL-1B

  Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)

  1 year

• Serum zinc

  Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)

  1 year

• 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)

  1 year

• Serum vitamin A

  Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

  1 year

Study Arms (2)

Intervention

PLACEBO COMPARATOR

* 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; Drug: Nifedipine; Drug: Beta Carotene; Drug: Vitamin D3; Drug: Dexamethasone

Control

ACTIVE COMPARATOR

* Nifedipin 4x10 mg * Dexamethasone 2x6 mg iv for 2 days

Drug: Nifedipine; Drug: Dexamethasone

Interventions

Zinc DRUG

included in intervention arm

Also known as: Zinc Picolinate 50 mg

Intervention

Nifedipine DRUG

included in intervention and control arm

Also known as: Nifedipine 10 mg

Control; Intervention

Beta Carotene DRUG

included in intervention arm

Also known as: Beta carotene 25,000 IU

Intervention

Vitamin D3 DRUG

included in intervention arm

Also known as: Cholecalciferol 50,000 IU

Intervention

Dexamethasone DRUG

included in intervention and control arm

Also known as: Dexamethasone 6 mg

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who has preterm birth in 26-36 weeks gestational age

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Premature Birth

Interventions

Zinc; picolinic acid; Nifedipine; beta Carotene; Cholecalciferol; Dexamethasone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share