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Zinc and Copper Absorption in Neonates With Bilious Losses

This study is currently recruiting participants.
Verified by Baylor College of Medicine, September 2008

Sponsored by: Baylor College of Medicine
Information provided by: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00738283
  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

MedlinePlus related topics:   Ostomy   

U.S. FDA Resources

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

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

Biospecimen Description:

Blood, stool, gastric residuals, and urine


Estimated Enrollment:   20
Study Start Date:   September 2008
Estimated Study Completion Date:   January 2010
Estimated Primary Completion Date:   September 2009 (Final data collection date for primary outcome measure)

Show detailed description  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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738283

Contacts
Contact: Keli M Hawthorne, MS, RD     713-798-7085     kelih@bcm.edu    
Contact: Kim Balay, MD     713-798-6707     kd131106@bcm.edu    

Locations
United States, Texas
Baylor College of Medicine     Recruiting
      Houston, Texas, United States, 77030
      Contact: Keli M Hawthorne, MS, RD     713-798-7085     kelih@bcm.edu    
Texas Children's Hospital     Recruiting
      Houston, Texas, United States, 77030
      Contact: Keli M Hawthorne, MS, RD     713-798-7085     kelih@bcm.edu    
Ben Taub General Hospital     Recruiting
      Houston, Texas, United States, 77030
      Contact: Keli M Hawthorne, MS, RD     713-798-7085     kelih@bcm.edu    

Sponsors and Collaborators
Baylor College of Medicine

Investigators
Principal Investigator:     Steven A Abrams, MD     Baylor College of Medicine    
  More Information


USDA/ARS Children's Nutrition Research Center  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   Baylor College of Medicine ( Steve Abrams, MD )
Study ID Numbers:   H-23224
First Received:   August 18, 2008
Last Updated:   September 9, 2008
ClinicalTrials.gov Identifier:   NCT00738283
Health Authority:   United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Zinc  
Copper  
Neonate  

Study placed in the following topic categories:
Zinc
Copper

ClinicalTrials.gov processed this record on October 15, 2008




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