NCT03005496

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• PreTerm Birth

Interventions

Type	Name	Description
DRUG	Zinc	included in intervention arm
DRUG	Nifedipine	included in intervention and control arm
DRUG	Beta Carotene	included in intervention arm
DRUG	Vitamin D3	included in intervention arm
DRUG	Dexamethasone	included in intervention and control arm

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2016-12-29
• Last updated: 2017-11-21