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

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT03005496

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2017

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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 Names: Zinc Picolinate 50 mg Drug: Nifedipine included in intervention and control arm Other Names: Nifedipine 10 mg Drug: Beta Carotene included in intervention arm Other Names: Beta carotene 25,000 IU Drug: Vitamin D3 included in intervention arm Other Names: Cholecalciferol 50,000 IU Drug: Dexamethasone included in intervention and control arm Other Names: 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 Names: Nifedipine 10 mg Drug: Dexamethasone included in intervention and control arm Other Names: Dexamethasone 6 mg

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 Names:

Zinc Picolinate 50 mg

Drug: Nifedipine

included in intervention and control arm

Other Names:

Nifedipine 10 mg

Drug: Beta Carotene

included in intervention arm

Other Names:

Beta carotene 25,000 IU

Drug: Vitamin D3

included in intervention arm

Other Names:

Cholecalciferol 50,000 IU

Drug: Dexamethasone

included in intervention and control arm

Other Names:

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 Names:

Nifedipine 10 mg

Drug: Dexamethasone

included in intervention and control arm

Other Names:

Dexamethasone 6 mg

Outcome Measures

Primary Outcome Measures

placenta MyD88 [1 year]
Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
placenta TRIF [1 year]
Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Placenta NFkB [1 year]
Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
Placenta 25(OH)D [1 year]
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 [1 year]
Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
Placenta zinc [1 year]
Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Placenta IL-1B [1 year]
Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)
Serum zinc [1 year]
Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
Serum 25(OH)D [1 year]
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 [1 year]
Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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