Zinc Homeostasis and Kinetics in Children With Cystic Fibrosis (CF)

This study has been completed.
Sponsor:
Information provided by:
Cystic Fibrosis Foundation Therapeutics
ClinicalTrials.gov Identifier:
NCT00104494
First received: March 1, 2005
Last updated: July 29, 2015
Last verified: March 2005
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zinc Homeostasis and Kinetics in Children With CF

Resource links provided by NLM:


Further study details as provided by Cystic Fibrosis Foundation Therapeutics:

Primary Outcome Measures:
  • Zinc balance [ Time Frame: 120h ]

Secondary Outcome Measures:
  • Serum ceruloplasmin [ Time Frame: 8wk ]
  • Serum copper [ Time Frame: 8wk ]
  • Serum ferritin [ Time Frame: 8wk ]

Enrollment: 30
Study Start Date: May 2004
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: 1
CF, Zinc acetate
Drug: Zinc acetate (20mg/d)
Randomized to receive either 20mg/d zinc as zinc acetate or an identical placebo
Experimental: 2
CF, Placebo
Drug: Zinc acetate (20mg/d)
Randomized to receive either 20mg/d zinc as zinc acetate or an identical placebo
No Intervention: 3
Controls

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

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cystic Fibrosis Foundation Therapeutics
Investigators
Principal Investigator: Ian J Griffin, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00104494     History of Changes
Other Study ID Numbers: GRIFFI04A0
Study First Received: March 1, 2005
Last Updated: July 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Cystic Fibrosis Foundation Therapeutics:
Cystic Fibrosis
Zinc supplementation
Nutrition
Zinc absorption
Zinc excretion
Zinc status

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on August 03, 2015