Ileostomy Clinical Trial
Official title:
Zinc and Copper Absorption in Neonates With Bilious Losses
Verified date | July 2015 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Jalla S, Krebs NF, Rodden D, Hambidge KM. Zinc homeostasis in premature infants does not differ between those fed preterm formula or fortified human milk. Pediatr Res. 2004 Oct;56(4):615-20. Epub 2004 Aug 4. — View Citation
Marriott LD, Foote KD, Kimber AC, Delves HT, Morgan JB. Zinc, copper, selenium and manganese blood levels in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2007 Nov;92(6):F494-7. Epub 2007 Apr 27. — View Citation
Sandström B, Andersson H, Kivistö B, Sandberg AS. Apparent small intestinal absorption of nitrogen and minerals from soy and meat-protein-based diets. A study on human ileostomy subjects. J Nutr. 1986 Nov;116(11):2209-18. — View Citation
Wastney ME, Angelus PA, Barnes RM, Subramanian KN. Zinc absorption, distribution, excretion, and retention by healthy preterm infants. Pediatr Res. 1999 Feb;45(2):191-6. — View Citation
Woolf GM, Miller C, Kurian R, Jeejeebhoy KN. Nutritional absorption in short bowel syndrome. Evaluation of fluid, calorie, and divalent cation requirements. Dig Dis Sci. 1987 Jan;32(1):8-15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Zinc Absorption | 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. |
96 hours after single feed infusion | No |
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