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Zinc and Copper Absorption in Neonates With Bilious Losses

This study has been completed.
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine Identifier:
First received: August 18, 2008
Last updated: March 13, 2017
Last verified: March 2017

We propose to examine the absorption and excretion of zinc and copper in infants with ostomies. This will be accomplished by measuring baseline excretion and serum levels of zinc, copper, and ceruloplasmin, and by utilizing stable isotopes of zinc and copper to measure absorption and excretion.

To determine how the presence of an ileostomy impacts zinc and copper metabolism in infants at three time points: 1) when the infant has an ostomy and is receiving the majority of calories from total parenteral nutrition (TPN); 2) when the infant has an ostomy and is receiving primarily enteral nutrition without TPN; and 3) when/if the infant has a surgery to reconnect the bowel and is receiving primarily enteral nutrition.

For the first part of the study, excretion data for zinc will be obtained for ostomy patients. We hypothesize that infants with an ostomy will excrete more zinc in their stools than healthy term or preterm infants without ostomies.

For the second part of the study, we will obtain data on zinc absorption, secretion, and excretion through use of stable isotopes. Jalla et al determined that healthy infants retain zinc of 0.4 mg/day. We hypothesize that due to increased zinc losses, the infants in the study will be less positive than the healthy infants in the study by Jalla et al. Our study is designed to be able to detect if the ostomy patients net retention is one-half that described by Jalla (i.e. 0.2 mg/d). We will also obtain data on copper absorption, secretion, and excretion through the use of stable isotopes in the second part of the study. As a pilot study, we do not fully know what to expect regarding copper levels in infants with ostomies, but we hypothesize that they may be less positive than healthy infants without ostomies. Also, we hypothesize that zinc and copper are competitively absorbed in the gut; therefore, infants who receive more zinc may absorb less copper.

For the third part of the study, we will obtain data on zinc absorption through the use of stable isotopes after the infant has had surgery to reanastomose the bowel. We hypothesize that there may be continued zinc losses above those documented for healthy infants who have never had an ostomy, but decreased losses compared to when the infant had an ostomy.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zinc and Copper Absorption in Neonates With Bilious Losses

Further study details as provided by Steve Abrams, MD, Baylor College of Medicine:

Primary Outcome Measures:
  • Zinc Absorption [ Time Frame: 96 hours after single feed infusion ]

    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.

Biospecimen Retention:   Samples Without DNA
Blood, stool, gastric residuals, and urine

Enrollment: 17
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from the patient population at the Neonatal Intensive Care Units of Texas Children's Hospital and Ben Taub General Hospital.

Inclusion Criteria:

  • Presence of ileostomy due to any disease or condition (i.e., necrotizing enterocolitis, intestinal atresias, gastroschisis, or intestinal perforations)
  • Minimum birth weight of 500g
  • Likely to survive

Exclusion Criteria:

  • Dysmotility of the gastrointestinal system
  • Major congenital anomalies, including heart disease
  • Meconium ileus
  • Not expected to survive for at least 2 weeks
  Contacts and Locations
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Please refer to this study by its identifier: NCT00738283

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Principal Investigator: Steven A Abrams, MD Baylor College of Medicine
  More Information

Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine Identifier: NCT00738283     History of Changes
Other Study ID Numbers: H-23224
Study First Received: August 18, 2008
Results First Received: September 24, 2012
Last Updated: March 13, 2017

Keywords provided by Steve Abrams, MD, Baylor College of Medicine:

Additional relevant MeSH terms:
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on May 25, 2017