Enteral Zinc Supplementation in Very Low Birth Weight Infants

NCT06433674 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 23-09580-FB
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Very Low Birth Weight Infant; Nutritional Deficiency

Outcome Measures

Primary Outcomes (1)

• Rate of weight gain

  The primary outcome would be the rate of weight gain in grams/kg/day

  at hospital discharge or 36 weeks PMA whichever comes first.

Secondary Outcomes (3)

• Length

  at hospital discharge of 36 weeks PMA whichever comes first

• Head Circumference

  at hospital discharge of 36 weeks PMA whichever comes first

• Zinc level

  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

Study Arms (2)

Zinc Sulfate

EXPERIMENTAL

The experimental group will receive \~1 mg/kg/day of elemental enteral Zinc

Drug: Zinc Sulfate

Placebo

PLACEBO COMPARATOR

The placebo group will receive a similar amount of sterile water in a colored syringe

Other: Sterile Water

Interventions

Zinc Sulfate DRUG

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.

Zinc Sulfate

Sterile Water OTHER

The placebo group with will receive a similar amount of sterile water in a colored syringe

Placebo

Eligibility Criteria

• Age: 25 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \< 1500 grams
• Infant is tolerating at least 100 ml/kg/day of enteral feeds
• At least 25wks PMA.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee: lead

Related Publications (5)

• 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.

  PMID: 24025633 BACKGROUND

• Brion 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.

  PMID: 33010794 BACKGROUND

• Terrin 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.

  PMID: 26690476 BACKGROUND

• Sinha 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.

  PMID: 35921675 BACKGROUND

• Shaikhkhalil 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.

  PMID: 24121149 RESULT

MeSH Terms

Conditions

Malnutrition

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Andrew C Mire, M.D.

  UTHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew C Mire, M.D.

CONTACT

2255884831; amire@uthsc.edu

Mark Weems, M.D.

CONTACT

mweems@uthsc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share