Enteral Zinc Supplementation in Very Low Birth Weight Infants

University of Tennessee

Status and phase: Not yet enrolling; Phase 3

Conditions: Very Low Birth Weight Infant; Nutritional Deficiency

Treatments: Drug: Zinc Sulfate; Other: Sterile Water

Study type: Interventional

Funder types: Other

Identifiers

NCT06433674

23-09580-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 25 to 36 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Zinc Sulfate

Experimental group

Description:

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

Treatment:

Drug: Zinc Sulfate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Sterile Water