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

PreTerm Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005496
• Other study ID #: 50/UN.2F1/ETIK/2016
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2016
• Last updated: November 18, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• PreTerm Birth

Intervention

Drug:
• Zinc
included in intervention arm
• Nifedipine
included in intervention and control arm
• Beta Carotene
included in intervention arm
• Vitamin D3
included in intervention arm
• Dexamethasone
included in intervention and control arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	placenta MyD88	Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)	1 year
Primary	placenta TRIF	Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)	1 year
Primary	Placenta NFkB	Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)	1 year
Primary	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
Primary	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
Primary	Placenta zinc	Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)	1 year
Primary	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
Primary	Serum zinc	Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)	1 year
Primary	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
Primary	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