## Protocol Section
### Identification Module
**NCT ID:** NCT06433674

**Brief Title:** Enteral Zinc Supplementation in VLBW Infants

**Official Title:** Enteral Zinc Supplementation in VLBW Infants

#### Organization Study ID Info
**ID:** 23-09580-FB
#### Organization
**Class:** OTHER
**Full Name:** University of Tennessee
### Status Module
#### Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Tennessee

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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 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 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Very Low Birth Weight Infant

- Nutritional Deficiency

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Zinc Sulfate

**Label:** Zinc Sulfate

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Sterile Water

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Zinc Sulfate

**Description:** 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.

**Name:** Zinc Sulfate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

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

**Name:** Sterile Water

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Rate of weight gain

**Time Frame:** at hospital discharge or 36 weeks PMA whichever comes first.

#### Secondary Outcomes

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

**Measure:** Length

**Time Frame:** at hospital discharge of 36 weeks PMA whichever comes first

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

**Measure:** Head Circumference

**Time Frame:** at hospital discharge of 36 weeks PMA whichever comes first

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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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 NEC (stage 2 or 3), bowel perforation, or bowel resection
* Infant who has tolerated ≥100 ml/kg/day prior to admission.

**Healthy Volunteers:** True

**Maximum Age:** 36 Weeks

**Minimum Age:** 25 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** amire@uthsc.edu

**Name:** Andrew C Mire, M.D.

**Phone:** 2255884831

**Role:** CONTACT

**Contact 2:**

**Email:** mweems@uthsc.edu

**Name:** Mark Weems, M.D.

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** UTHSC

**Name:** Andrew C Mire, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 24025633

**Citation:** 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. Erratum In: Pediatr Res. 2021 Mar 2;:

**PMID:** 33010794

**Citation:** 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.

**PMID:** 26690476

**Citation:** 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.

**PMID:** 35921675

**Citation:** 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.

**PMID:** 24121149

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001835

- Term: Body Weight

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M25306

- Name: Malnutrition

- Relevance: HIGH

- As Found: Nutritional Deficiency

- ID: M5006

- Name: Birth Weight

- Relevance: HIGH

- As Found: Birth Weight

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000044342

- Term: Malnutrition

- ID: D000001724

- Term: Birth Weight

### Intervention Browse Module - Ancestors

- ID: D000001252

- Term: Astringents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000003879

- Term: Dermatologic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M21269

- Name: Zinc Sulfate

- Relevance: HIGH

- As Found: Systolic blood pressure

- ID: M17768

- Name: Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M4559

- Name: Astringents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019287

- Term: Zinc Sulfate

### Misc Info Module

- Version Holder: 2024-05-31
