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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc Sulfate | Experimental | The experimental group will receive ~1 mg/kg/day of elemental enteral Zinc |
|
| Placebo | Placebo Comparator | The placebo group will receive a similar amount of sterile water in a colored syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length | This secondary outcome would be the rate of length gain in cm/day | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew C Mire, M.D. | Contact | 2255884831 | amire@uthsc.edu | |
| Mark Weems, M.D. | Contact | mweems@uthsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew C Mire, M.D. | UTHSC | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24025633 | Background | 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. | |
| 33010794 |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo
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|
| Sterile Water | Other | The placebo group with will receive a similar amount of sterile water in a colored syringe |
|
| 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 | 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 |
| 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. |
| 26690476 | 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. |
| 35921675 | 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. |
| 24121149 | Result | 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. |
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |