Zinc and Copper Absorption in Neonates With Bilious Losses
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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 |
- 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 ]
- 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 |
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| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| Ben Taub General Hospital | |
| Houston, Texas, United States, 77030 | |
| 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 |
Additional relevant MeSH terms:
|
Copper Trace Elements Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013