Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06433674
Study type Interventional
Source University of Tennessee
Contact Andrew C Mire, M.D.
Phone 2255884831
Email amire@uthsc.edu
Status Not yet recruiting
Phase Phase 3
Start date June 1, 2024
Completion date July 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05603585 - Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Completed NCT04091165 - Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
Recruiting NCT05655910 - Enhanced Nutritional Optimization in LVAD Trial N/A
Completed NCT04117581 - A Study to Investigate the Effect of Vitamin D3 Supplementation on Asthma Symptoms in Adults With Asthma (VITDAS) N/A
Recruiting NCT06078488 - Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries. N/A
Withdrawn NCT05073562 - Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia N/A
Completed NCT02208635 - Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months N/A
Recruiting NCT01342861 - INAPEN Protocol for Impact of Breakfast Improvement N/A
Completed NCT05244785 - Health and Nutrition Survey on Shenzhen Children
Recruiting NCT06103526 - Immunonutrition in ERAS Protocols in Gynecologic Oncology N/A
Completed NCT05473546 - Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)
Completed NCT04829851 - The PROTEIN Project
Completed NCT03202576 - Nasogastric Tube Securement Comparison Study N/A
Completed NCT04351828 - Intestinal Permeability, Nutritional Status and Quality of Life in Celiac Disease
Completed NCT04866927 - Bioavailability of Proteins From Plant Based Diets
Completed NCT04771377 - Effect of Protein Supplementation and a Structured Exercise Program on Muscle in Women After Bariatric Surgery. N/A
Completed NCT04401930 - Eating Habits and Lifestyle Profile of an Italian Aging Cohort
Terminated NCT04629534 - Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study Phase 4
Completed NCT03133364 - Developing and Testing Delicious and Nutritious for the Old People N/A