Trial Outcomes & Findings for Zinc and Copper Absorption in Neonates With Bilious Losses (NCT NCT00738283)

Results Overview

Zinc fractional absorption was measured using a dual tracer stable isotope method in which 67Zn was given orally with a single feed followed immediately by infusion of 70Zn intravenously. A spot urine sample was collected 96 hours after the infusion and the relative dose-corrected enrichments used to calculate fractional absorption at the time oral isotope was administered. Tracer:tracee ratios (TTR), measured by ICP-MS, were used to calculated fractional zinc absorption.

Recruitment status

COMPLETED

Target enrollment

17 participants

Primary outcome timeframe

96 hours after single feed infusion

Results posted on

2017-04-11

Participant Flow

Subjects were recruited in the Neonatal Intensive Care Unit at Texas Children's Hospital between September 2008 and May 2010.

Participant milestones

Participant milestones
Measure	Observational Group Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was \> 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Observational Group Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was \> 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
Overall Study Death	1
Overall Study Transfer to another facility	2
Overall Study Discharge home prior to end of study	1

Baseline Characteristics

Zinc and Copper Absorption in Neonates With Bilious Losses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational Group n=17 Participants Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was \> 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
Age, Categorical <=18 years	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44 days of life STANDARD_DEVIATION 23 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 96 hours after single feed infusion

Population: Relationships between zinc absorption, zinc excretion (urine or fecal) and zinc balance, and potential explanatory variables were analyzed using the GLM model function of JMP 7 for Macintosh (SAS inc, Cary, NC). Simple and multiple regression analysis were used as appropriate. Significance was assumed at a p \< 0.05.

Zinc fractional absorption was measured using a dual tracer stable isotope method in which 67Zn was given orally with a single feed followed immediately by infusion of 70Zn intravenously. A spot urine sample was collected 96 hours after the infusion and the relative dose-corrected enrichments used to calculate fractional absorption at the time oral isotope was administered. Tracer:tracee ratios (TTR), measured by ICP-MS, were used to calculated fractional zinc absorption.

Outcome measures

Outcome measures
Measure	Observational Group n=13 Participants Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was \> 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
Zinc Absorption	10.9 fractional zinc absorption (%) Standard Deviation 5.3

Adverse Events

Observational Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven A. Abrams, MD

Baylor College of Medicine

Phone: 713-798-7164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place