Enteral Zinc Supplementation in Very Low Birth Weight Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-07-01

Brief Summary

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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

* 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.

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Detailed Description

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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.

Conditions

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Very Low Birth Weight Infant Nutritional Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zinc Sulfate

The experimental group will receive \~1 mg/kg/day of elemental enteral Zinc

Group Type EXPERIMENTAL

Zinc Sulfate

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Sterile Water

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Sterile Water

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

25 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes