Zinc and Copper Absorption in Neonates With Bilious Losses

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00738283
First received: August 18, 2008
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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.


Condition
Ileostomy

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

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Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • The primary objective of this study revolves around part 2, the stable isotope portion of zinc and copper absorption, secretion, and excretion in infants with an ostomy. There is currently no data available in this population for zinc balance. [ Time Frame: Assessed at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional objectives that will be accomplished by the study include establishment of baseline secretion of zinc while on TPN in part one of the study, and determination of the effect of reanastomosis on zinc secretion in the third part of the study. [ Time Frame: Assessed at the end of the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood, stool, gastric residuals, and urine


Estimated Enrollment: 20
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

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT00738283

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

Additional Information:
Publications:
Responsible Party: Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00738283     History of Changes
Other Study ID Numbers: H-23224
Study First Received: August 18, 2008
Last Updated: December 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Zinc
Copper
Neonate

ClinicalTrials.gov processed this record on October 23, 2014