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NCT03532555 · ClinicalTrials.gov registry record · NA
Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
A NA study, sponsored by University of Utah.
- Terminated
- Registry status
- NA
- Development phase
- 37
- Enrollment target
NCT03532555 is a NA study that was terminated before completion, run by University of Utah. The registered enrollment target is 37 participants.
The verdict
NCT03532555, a NA study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
Study Summary
Multiple factors contribute to growth failure in infants with BPD, including poor nutrient stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to infants without BPD, those with BPD have increased resting metabolic rates and energy expenditure. Growth deficits manifest as lower weight, length, and head circumference, as well as changes in body composition. These deficits precede the development of BPD and persist post-discharge. While similar rates of growth are observed in very low birth weight infants with and without BPD once receiving equal calories, catch up growth does not occur in the BPD group. Thus, early growth deficits remained uncompensated. After iron, zinc is the most metabolically active trace element in the human body. It has a critical role in growth, through its actions on growth hormone, IGF-1, IGFBP-3, and bone metabolism. Prematurity is a risk factor for zinc deficiency, as 60% of zinc accretion occurs in the third trimester. Impaired intake and absorption or excess excretion can further increase this risk. Finally, periods of rapid growth, as seen in preterm infants, increase the need for zinc. Biochemically, zinc deficiency is defined by a serum zinc level less than 55mcg/dl. However, while zinc depletion is associated with deficiency, the opposite may not be true. For example, in starving patients, clinical symptoms of zinc deficiency occur during re-feeding, suggesting overall requirements are related to needs, regardless of overall zinc status. This may be the case in preterm infants, who may have a subclinical deficiency despite serum zinc level. Thus, zinc deficiency should be considered in infants with poor growth despite receiving adequate protein and calories. The objective of this study is to determine whether enteral zinc supplementation leads to improved growth in infants at risk for bronchopulmonary dysplasia (BPD). The investigator's hypothesis is that enteral zinc supplementation in very pre
Interventions
- DIETARY_SUPPLEMENT Zinc Acetate
- OTHER No supplemental zinc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2022-08-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03532555
The ClinicalTrials.gov registry entry for NCT03532555 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Zinc Acetate is the first listed.
NCT03532555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03532555 about?
NCT03532555 is a clinical study titled "Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia". Multiple factors contribute to growth failure in infants with BPD, including poor nutrient stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to infants without BPD, those with BPD have increased resting metabolic rates and energy expenditure. Growth deficits man...
What is the current status of trial NCT03532555?
This trial is currently terminated. It is a NA study. The enrollment target is 37 participants. The study started on 2018-03-22. Estimated completion is 2022-08-25.
What interventions are being tested in trial NCT03532555?
The interventions under investigation include: Zinc Acetate (DIETARY_SUPPLEMENT), No supplemental zinc (OTHER).
Who is sponsoring clinical trial NCT03532555?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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