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Enteral Zinc Supplementation in Very Low Birth Weight Infants

ConditionsVery Low Birth Weight InfantNutritional Deficiency
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age25-36
SponsorUniversity of Tennessee

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Birth weight < 1500 grams

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

At least 25wks PMA.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Sterile Water

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Zinc SulfateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of weight gain

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

Time frame
at hospital discharge or 36 weeks PMA whichever comes first.

Secondary outcomes

1

Length

This secondary outcome would be the rate of length gain in cm/day

Time frame
at hospital discharge of 36 weeks PMA whichever comes first
2

Head Circumference

This secondary outcome would be the rate of head circumference gain in cm/day

Time frame
at hospital discharge of 36 weeks PMA whichever comes first
3

Zinc level

This secondary outcome would be looking for a statically significant difference in zinc level

Time frame
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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: