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

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ClinicalTrials.gov Identifier: NCT00104494
Recruitment Status : Completed
First Posted : March 2, 2005
Last Update Posted : July 30, 2015
Information provided by:
Cystic Fibrosis Foundation

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Zinc acetate (20mg/d) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zinc Homeostasis and Kinetics in Children With CF
Study Start Date : May 2004
Actual Study Completion Date : September 2007

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Serum ceruloplasmin [ Time Frame: 8wk ]
  2. Serum copper [ Time Frame: 8wk ]
  3. Serum ferritin [ Time Frame: 8wk ]

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104494

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cystic Fibrosis Foundation
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Principal Investigator: Ian J Griffin, MD Baylor College of Medicine
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ClinicalTrials.gov Identifier: NCT00104494    
Other Study ID Numbers: GRIFFI04A0
First Posted: March 2, 2005    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: March 2005
Keywords provided by Cystic Fibrosis Foundation:
Cystic Fibrosis
Zinc supplementation
Zinc absorption
Zinc excretion
Zinc status
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases