Enteral Zinc Supplementation in Very Low Birth Weight Infants

Nutritional Deficiency Clinical Trial

Official title:

Enteral Zinc Supplementation in Very Low Birth Weight Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433674
• Other study ID #: 23-09580-FB
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: University of Tennessee
• Contact: Andrew C Mire, M.D.
• Phone: 2255884831
• Email: amire[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

1. Birth weight < 1500 grams

2. Infant is tolerating at least 100 ml/kg/day of enteral feeds

3. At least 25wks PMA.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Malnutrition
• Nutritional Deficiency
• Very Low Birth Weight Infant

Intervention

Drug:
• Zinc Sulfate
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.

Other:
• Sterile Water
The placebo group with will receive a similar amount of sterile water in a colored syringe

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

References & Publications (5)

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. Erratum In: Pediatr Res. 2021 Mar 2;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length	This secondary outcome would be the rate of length gain in cm/day	at hospital discharge of 36 weeks PMA whichever comes first
Secondary	Head Circumference	This secondary outcome would be the rate of head circumference gain in cm/day	at hospital discharge of 36 weeks PMA whichever comes first
Secondary	Zinc level	This secondary outcome would be looking for a statically significant difference in 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