Nutritional Deficiency Clinical Trial
Official title:
Enteral Zinc Supplementation in Very Low Birth Weight Infants
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Tennessee |
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
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 |
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