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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Placebo Comparator |
|
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| Control | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc | Drug | included in intervention arm |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 27, 2019 | |
| Reset | Mar 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 27, 2019 | Mar 19, 2019 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| C030614 | picolinic acid |
| D009543 | Nifedipine |
| D019207 | beta Carotene |
| D002762 | Cholecalciferol |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Nifedipine | Drug | included in intervention and control arm |
|
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| Beta Carotene | Drug | included in intervention arm |
|
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| Vitamin D3 | Drug | included in intervention arm |
|
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| Dexamethasone | Drug | included in intervention and control arm |
|
|
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 |
| D000091642 | Urogenital Diseases |
| D008670 |
| Metals |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013259 | Steroids, Fluorinated |