Zinc and Copper Absorption in Neonates With Bilious Losses

NCT00738283 | Completed Results

• 1 other identifier: H-23224
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Ileostomy

Keywords

Zinc; Copper; Neonate

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Dysmotility of the gastrointestinal system
• Major congenital anomalies, including heart disease
• Meconium ileus
• Not expected to survive for at least 2 weeks

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (5)

• 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. doi: 10.1203/00006450-199902000-00006.

  PMID: 10022589 BACKGROUND

• 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. doi: 10.1136/adc.2006.107755. Epub 2007 Apr 27.

  PMID: 17468128 BACKGROUND

• 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. doi: 10.1203/01.PDR.0000139428.77791.3D. Epub 2004 Aug 4.

  PMID: 15295087 BACKGROUND

• Sandstrom B, Andersson H, Kivisto 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. doi: 10.1093/jn/116.11.2209.

  PMID: 3025388 BACKGROUND

• 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. doi: 10.1007/BF01296681.

  PMID: 3792183 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, stool, gastric residuals, and urine

Limitations and Caveats

Only 10 infants achieved a majority of enteral feeds with the ostomy in place, of which only 7 were fully enterally fed at the time of the study. This is a mixed group, but nonetheless representative of infants with small intestinal ostomies.

Results Point of Contact

• Title: Steven A. Abrams, MD
• Organization: Baylor College of Medicine

sabrams@bcm.edu

713-798-7164

Study Officials

• Steven A Abrams, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 11, 2017
• Results First Posted: August 21, 2015

Record last verified: 2017-03

Locations

US (2)