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PreTerm BirthPhase 4NCT03005496

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

A Phase 4 study testing Zinc, Nifedipine and Beta Carotene in people with PreTerm Birth, run by Universitas Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
PreTerm Birth
What is being tested?
Zinc, Nifedipine and Beta Carotene
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
No sites listed yet
Study dates
Jan 2017to Jun 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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.

Read the 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
Being tested
Zinc, Nifedipine, Beta Carotene, Vitamin D3, Dexamethasone
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZincDrug

    Also called Zinc Picolinate 50 mg

    included in intervention arm

  • NifedipineDrug

    Also called Nifedipine 10 mg

    included in intervention and control arm

  • Beta CaroteneDrug

    Also called Beta carotene 25,000 IU

    included in intervention arm

  • Vitamin D3Drug

    Also called Cholecalciferol 50,000 IU

    included in intervention arm

  • DexamethasoneDrug

    Also called Dexamethasone 6 mg

    included in intervention and control arm

Study groups in NCT03005496
Study groupRoleWhat they receive
InterventionPlacebo 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
Receives: Drug: Zinc; Drug: Nifedipine; Drug: Beta Carotene; Drug: Vitamin D3; Drug: Dexamethasone
ControlActive comparator* Nifedipin 4x10 mg * Dexamethasone 2x6 mg iv for 2 days
Receives: Drug: Nifedipine; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. placenta MyD88

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

    Measured: 1 year

  2. placenta TRIF

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

    Measured: 1 year

  3. Placenta NFkB

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

    Measured: 1 year

  4. 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)

    Measured: 1 year

  5. Placenta vitamin A

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

    Measured: 1 year

  6. Placenta zinc

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

    Measured: 1 year

  7. Placenta IL-1B

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

    Measured: 1 year

  8. Serum zinc

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

    Measured: 1 year

  9. 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)

    Measured: 1 year

  10. Serum vitamin A

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionApr 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03005496
Sponsor's protocol ID
50/UN.2F1/ETIK/2016
Status last verified
Nov 2017
First submitted
19 Dec 2016
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zinc, Nifedipine and Beta Carotene in people with PreTerm Birth, run by Universitas Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

placenta MyD88 (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03005496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.

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