Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00738283 · ClinicalTrials.gov registry record
Zinc and Copper Absorption in Neonates With Bilious Losses
A clinical trial of Ileostomy, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 17
- Enrollment target
- 2
- Study locations
NCT00738283 is a study of Ileostomy that has completed, run by Baylor College of Medicine. The registered enrollment target is 17 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT00738283, a study of Ileostomy, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
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 thr
Conditions Studied
Study Locations (2)
Texas
- Baylor College of Medicine - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00738283
The ClinicalTrials.gov registry entry for NCT00738283 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ileostomy appearing as the primary indexed condition, and to 0 interventions.
NCT00738283 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00738283 about?
NCT00738283 is a clinical study titled "Zinc and Copper Absorption in Neonates With Bilious Losses". 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 ...
What is the current status of trial NCT00738283?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2008-09. Estimated completion is 2010-12.
What conditions does trial NCT00738283 study?
This clinical trial studies the following conditions: Ileostomy.
Who is sponsoring clinical trial NCT00738283?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00738283 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ileostomy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.