Very Low Birth Weight InfantPhase 3NCT06433674
Enteral Zinc Supplementation in Very Low Birth Weight Infants
A Phase 3 study testing Zinc Sulfate and Sterile Water in people with Very Low Birth Weight Infant and Nutritional Deficiency, run by University of Tennessee.
Trial summary
The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. Read more about this study
- Who is it for?
- Ages 25 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Very Low Birth Weight Infant, Nutritional Deficiency
- What is being tested?
- Zinc Sulfate and Sterile Water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jul 2025
- Phase
- Phase 3
- 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 25 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight < 1500 grams
- Infant is tolerating at least 100 ml/kg/day of enteral feeds
- At least 25wks PMA.
Who cannot join
- Major congenital malformations especially anomaly of the GI tract
- Major congenital heart disease (i.e.: ductal dependent lesion)
- Previously diagnosed necrotizing enterocolitis (stage 2 or 3), bowel perforation, or bowel resection
- Infant who has tolerated ≥100 ml/kg/day prior to admission.
Trial locations and contacts
No sites are listed yet.
Mark Weems, M.D. contact
About this study
The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
- Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
- Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive ~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks postmenstrual age (PMA) or hospital discharge, whichever comes first.
- The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
Read the detailed description
This is a prospective, single center, randomized, double blinded, placebo controlled clinical trial. The goal of this clinical trial is to observe for changes in rate of weight gain in the VLBW infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
- Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
- Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized using sealed envelopes. The subjects will be randomly selected to one of two groups. The treatment group will receive ~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. Only the pharmacy will know which patient is receiving the Zinc Sulfate and which patient is receiving the placebo. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks PMA or hospital discharge, whichever comes first.
- The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
- Being tested
- Zinc Sulfate, Sterile Water
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDrug
The pharmacy will be the one preparing the Zinc sulfate. The zinc sulfate comes in 220 mg tablets which are then mixed with 1 ml of Oral plus (a common suspending agent) as well as 9 ml of Sterile water. This then makes a Zinc Sulfate 22 mg/ml oral suspension which will be dispensed in an amber syringe.
Sterile WaterOther
The placebo group with will receive a similar amount of sterile water in a colored syringe
| Study group | Role | What they receive |
|---|---|---|
| Zinc Sulfate | Experimental | The experimental group will receive ~1 mg/kg/day of elemental enteral Zinc Receives: Drug: Zinc Sulfate |
| Placebo | Placebo comparator | The placebo group will receive a similar amount of sterile water in a colored syringe Receives: Other: Sterile Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weight gain
The primary outcome would be the rate of weight gain in grams/kg/day
Measured: at hospital discharge or 36 weeks PMA whichever comes first.
Secondary outcomes (3)
Length
This secondary outcome would be the rate of length gain in cm/day
Measured: at hospital discharge of 36 weeks PMA whichever comes first
Head Circumference
This secondary outcome would be the rate of head circumference gain in cm/day
Measured: at hospital discharge of 36 weeks PMA whichever comes first
Zinc level
This secondary outcome would be looking for a statically significant difference in zinc level
Measured: Comparing the initial zinc level to the four week zinc level as well as the zinc level at 36 weeks or discharge whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew C Mire, M.D., Principal investigator, UTHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433674
- Sponsor's protocol ID
- 23-09580-FB
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terrin G, Berni Canani R, Passariello A, Messina F, Conti MG, Caoci S, Smaldore A, Bertino E, De Curtis M. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country. Am J Clin Nutr. 2013 Dec;98(6):1468-74. doi: 10.3945/ajcn.112.054478. Epub 2013 Sep 11.
PubMed 24025633Brion LP, Heyne R, Lair CS. Role of zinc in neonatal growth and brain growth: review and scoping review. Pediatr Res. 2021 May;89(7):1627-1640. doi: 10.1038/s41390-020-01181-z. Epub 2020 Oct 3.
PubMed 33010794Terrin G, Berni Canani R, Di Chiara M, Pietravalle A, Aleandri V, Conte F, De Curtis M. Zinc in Early Life: A Key Element in the Fetus and Preterm Neonate. Nutrients. 2015 Dec 11;7(12):10427-46. doi: 10.3390/nu7125542.
PubMed 26690476Sinha B, Dudeja N, Chowdhury R, Choudhary TS, Upadhyay RP, Rongsen-Chandola T, Mazumder S, Taneja S, Bhandari N. Enteral Zinc Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysis. Pediatrics. 2022 Aug 1;150(Suppl 1):e2022057092J. doi: 10.1542/peds.2022-057092J.
PubMed 35921675Shaikhkhalil AK, Curtiss J, Puthoff TD, Valentine CJ. Enteral zinc supplementation and growth in extremely-low-birth-weight infants with chronic lung disease. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):183-7. doi: 10.1097/MPG.0000000000000145.
PubMed 24121149
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Zinc Supplementation in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT06433674
- Acronym / sponsor ID
- 23-09580-FB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 30 May 2024 (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.
The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
- Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
- Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive ~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks postmenstrual age (PMA) or hospital discharge, whichever comes first.
- The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
Detailed description
This is a prospective, single center, randomized, double blinded, placebo controlled clinical trial. The goal of this clinical trial is to observe for changes in rate of weight gain in the VLBW infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
- Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
- Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized using sealed envelopes. The subjects will be randomly selected to one of two groups. The treatment group will receive ~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. Only the pharmacy will know which patient is receiving the Zinc Sulfate and which patient is receiving the placebo. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks PMA or hospital discharge, whichever comes first.
- The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo
| Arm | Type | Receives |
|---|---|---|
| Zinc Sulfate | Experimental | Drug: Zinc SulfateThe experimental group will receive ~1 mg/kg/day of elemental enteral Zinc |
| Placebo | Placebo comparator | Other: Sterile WaterThe placebo group will receive a similar amount of sterile water in a colored syringe |
Who may qualify
- Ages
- 25 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight < 1500 grams
- Infant is tolerating at least 100 ml/kg/day of enteral feeds
- At least 25wks PMA.
Key exclusion criteria (4 listed)
- Major congenital malformations especially anomaly of the GI tract
- Major congenital heart disease (i.e.: ductal dependent lesion)
- Previously diagnosed necrotizing enterocolitis (stage 2 or 3), bowel perforation, or bowel resection
- Infant who has tolerated ≥100 ml/kg/day prior to admission.
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 SulfateThe pharmacy will be the one preparing the Zinc sulfate. The zinc sulfate comes in 220 mg tablets which are then mixed with 1 ml of Oral plus (a common suspending agent) as well as 9 ml of Sterile water. This then makes a Zinc Sulfate 22 mg/ml oral suspension which will be dispensed in an amber syringe. | Drug | Zinc Sulfate |
| Sterile WaterThe placebo group with will receive a similar amount of sterile water in a colored syringe | Other | Placebo |
Primary outcome
Rate of weight gain
Time frame: at hospital discharge or 36 weeks PMA whichever comes first.
The primary outcome would be the rate of weight gain in grams/kg/day
3 secondary outcomes
Length
Time frame: at hospital discharge of 36 weeks PMA whichever comes first
Head Circumference
Time frame: at hospital discharge of 36 weeks PMA whichever comes first
Zinc level
Time frame: Comparing the initial zinc level to the four week zinc level as well as the zinc level at 36 weeks or discharge whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 24025633Terrin G, Berni Canani R, Passariello A, Messina F, Conti MG, Caoci S, Smaldore A, Bertino E, De Curtis M. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country. Am J Clin Nutr. 2013 Dec;98(6):1468-74. doi: 10.3945/ajcn.112.054478. Epub 2013 Sep 11.
- Background: PubMed 33010794Brion LP, Heyne R, Lair CS. Role of zinc in neonatal growth and brain growth: review and scoping review. Pediatr Res. 2021 May;89(7):1627-1640. doi: 10.1038/s41390-020-01181-z. Epub 2020 Oct 3.
- Background: PubMed 26690476Terrin G, Berni Canani R, Di Chiara M, Pietravalle A, Aleandri V, Conte F, De Curtis M. Zinc in Early Life: A Key Element in the Fetus and Preterm Neonate. Nutrients. 2015 Dec 11;7(12):10427-46. doi: 10.3390/nu7125542.
- Background: PubMed 35921675Sinha B, Dudeja N, Chowdhury R, Choudhary TS, Upadhyay RP, Rongsen-Chandola T, Mazumder S, Taneja S, Bhandari N. Enteral Zinc Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysis. Pediatrics. 2022 Aug 1;150(Suppl 1):e2022057092J. doi: 10.1542/peds.2022-057092J.
- Results publication: PubMed 24121149Shaikhkhalil AK, Curtiss J, Puthoff TD, Valentine CJ. Enteral zinc supplementation and growth in extremely-low-birth-weight infants with chronic lung disease. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):183-7. doi: 10.1097/MPG.0000000000000145.
- 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.
Mark Weems, M.D. contact
Andrew C Mire, M.D. principal investigator
UTHSC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zinc Sulfate and Sterile Water in people with Very Low Birth Weight Infant and Nutritional Deficiency, run by University of Tennessee.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew C Mire, M.D. (2255884831, amire@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of weight gain (time frame: at hospital discharge or 36 weeks PMA whichever comes first.). 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 NCT06433674, which also lists 5 linked publications.
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 6 Jun 2024.