Preterm InfantPhase 4NCT05311540
Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
A Phase 4 study testing Zinc Sulfate in people with Preterm Infant and Effect of Drugs, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems. Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life. Read more about this study
- Who is it for?
- Ages 7 to 9 days
- Conditions the study is for
- Preterm Infant, Effect of Drugs, Zinc Deficiency Disease
- What is being tested?
- Zinc Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2014to 20 Apr 2015
- 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 7 to 9 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- < 32 weeks gestational age and/or <1500 gr birth weight
- Born in the study hospital
- Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient
Who cannot join
- Major congenital malformations and/or critical congenital heart defects
- Born in another hospital
- Severe birth asphyxia
- Severe sepsis
- Previous early-onset NEC history
- Infants on the intervention arm who did not continue Zinc supplementation during the study period
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- Hemodynamically unstability
- Infants nil per os
- No consent from the family
- Death before the 7th day of life
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Democracy University Faculty of Medicine
Izmir, 35290
About this study
- Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.
- Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life.
- Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.
- There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants.
- Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.
Read the detailed description
Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS).
Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of <32 weeks were randomly allocated on the seventh day of life to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge. Outcome measures were feeding intolerance, NEC (stage≥2), LOS and mortality.
- Conditions
- Preterm Infant, Effect of Drugs, Zinc Deficiency Disease
- Being tested
- Zinc Sulfate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| Zinc intervention | Experimental | 9 mg/day Zinc suspension via og tube along with the routinely used standard multivitamin product containing 3 mg daily dose of Zn, started on day 7 until discharge from hospital Receives: Drug: Zinc Sulfate |
| Control | No intervention | These infants received only standard commercial multivitamin product containing 3 mg daily dose of Zn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of feeding intolerance
Measured: through study completion, an average of 6 months
Secondary outcomes (6)
Duration of hospitalization
Measured: through study completion, an average of 6 months
Number of participants with necrotising enterocolitis (stage≥2)
Measured: through study completion, an average of 6 months
Incidence of mortality
Measured: through study completion, an average of 6 months
Number of participants with late onset sepsis
Measured: through study completion, an average of 6 months
Number of participants with retinopathy of prematurity
Measured: through study completion, an average of 6 months
Number of participants with bronchopulmonary dysplasia
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start14 Mar 2014
- Primary completion2 Mar 2015
- Study completion20 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Suzan Sahin, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311540
- Sponsor's protocol ID
- ZincVLBW
- Status last verified
- Feb 2023
- First submitted
- 19 May 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05311540
- Acronym / sponsor ID
- ZincVLBW
- Conditions
- Preterm Infant, Effect of Drugs, Zinc Deficiency Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 14 Mar 2014 (actual)
- Primary completion
- 2 Mar 2015 (actual)
- Study completion
- 20 Apr 2015 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.
- Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life.
- Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.
- There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants.
- Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.
Detailed description
Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS).
Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of <32 weeks were randomly allocated on the seventh day of life to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge. Outcome measures were feeding intolerance, NEC (stage≥2), LOS and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc intervention | Experimental | Drug: Zinc Sulfate9 mg/day Zinc suspension via og tube along with the routinely used standard multivitamin product containing 3 mg daily dose of Zn, started on day 7 until discharge from hospital |
| Control | No intervention | –These infants received only standard commercial multivitamin product containing 3 mg daily dose of Zn |
Who may qualify
- Ages
- 7 to 9 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- < 32 weeks gestational age and/or <1500 gr birth weight
- Born in the study hospital
- Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient
Key exclusion criteria (10 listed)
- Major congenital malformations and/or critical congenital heart defects
- Born in another hospital
- Severe birth asphyxia
- Severe sepsis
- Previous early-onset NEC history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Sulfate | Drug | Zinc intervention |
Primary outcome
Incidence of feeding intolerance
Time frame: through study completion, an average of 6 months
6 secondary outcomes
Duration of hospitalization
Time frame: through study completion, an average of 6 months
Number of participants with necrotising enterocolitis (stage≥2)
Time frame: through study completion, an average of 6 months
Incidence of mortality
Time frame: through study completion, an average of 6 months
Number of participants with late onset sepsis
Time frame: through study completion, an average of 6 months
Number of participants with retinopathy of prematurity
Time frame: through study completion, an average of 6 months
Number of participants with bronchopulmonary dysplasia
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc Sulfate in people with Preterm Infant and Effect of Drugs, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Incidence of feeding intolerance (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.