Zinc Homeostasis and Kinetics in Children With Cystic Fibrosis (CF) - Full Text View

Sponsored by:	Cystic Fibrosis Foundation
Information provided by:	Cystic Fibrosis Foundation
ClinicalTrials.gov Identifier:	NCT00104494

Purpose

Zinc deficiency has occasionally been reported in CF, but the need for additional zinc is unclear. We will examine the effect of additional zinc supplements on zinc absorption, zinc excretion, zinc balance and zinc kinetics in children with CF. Twelve children with CF will receive additional zinc, and twelve will not. We will also compare the children with CF to 12 healthy children without CF. We hypothesize that children with CF will have poor zinc absorption and high zinc excretion, leading to poor zinc balance and abnormal zinc kinetics. We hypothesize that those children with CF who are given zinc supplements will have higher zinc balance and more normal zinc kinetics than those without supplementation, and that zinc balance and zinc kinetics will be similar to healthy children.

Condition	Intervention
Cystic Fibrosis	Drug: Zinc acetate (20mg/d)

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Zinc acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Zinc Homeostasis and Kinetics in Children With CF

Further study details as provided by Cystic Fibrosis Foundation:

Primary Outcome Measures:

Zinc absorption
Endogenous fecal zinc excretion
Urinary zinc excretion
Zinc balance
Zinc kinetics

Secondary Outcome Measures:

Serum ceruloplasmin
Serum copper
Serum ferritin

Estimated Enrollment:	36
Study Start Date:	May 2004
Estimated Study Completion Date:	July 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	8 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Aged 8-14 years old
Have clinical pancreatic insufficiency (defined as the need for pancreatic enzyme replacement)
Have no other medical problems except CF (and its complications)
Weigh > 25kg

Exclusion Criteria:

Are taking any medicines (other than for CF and its complications)
Have known pancreatic endocrine dysfunction
Are taking more than 10 mg/d elemental zinc supplements
Have had major GI surgery, including gut resection, but not including surgery for decompression of meconium ileus (if this was the presenting feature of CF)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104494

Locations

United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Keli Hawthorne, RN 713-798-7085 Kelih@bcm.tmc.edu
Contact: Ian J Griffin, MD 713-798-7021 igriffin@bcm.tmc.edu
Principal Investigator: Ian J Griffin, MD
Sub-Investigator: Dan K Seilheimer, MD
Sub-Investigator: Steven A Abrams, MD
Sub-Investigator: E O Smith, PhD

Sponsors and Collaborators

Cystic Fibrosis Foundation

Investigators

Principal Investigator:

Ian J Griffin, MD

Baylor College of Medicine

More Information

Children's Nutrition Research Center, Baylor College of Medicine This link exits the ClinicalTrials.gov site

CF clinic, Texas Children's Hospital, Baylor College of Medicine This link exits the ClinicalTrials.gov site

Study ID Numbers:	GRIFFI04A0
Study First Received:	March 1, 2005
Last Updated:	February 17, 2006
ClinicalTrials.gov Identifier:	NCT00104494
Health Authority:	United States: Institutional Review Board

Keywords provided by Cystic Fibrosis Foundation:

Cystic Fibrosis
Zinc supplementation
Nutrition

Zinc absorption
Zinc excretion
Zinc status

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Zinc
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes
Growth Substances
Physiological Effects of Drugs

Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009