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

NCT00104494 | Completed DMC

• 1 other identifier: GRIFFI04A0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Zinc supplementation; Nutrition; Zinc absorption; Zinc excretion; Zinc status

Outcome Measures

Primary Outcomes (1)

• Zinc balance

  120h

Secondary Outcomes (3)

• Serum ceruloplasmin

  8wk

• Serum copper

  8wk

• Serum ferritin

  8wk

Study Arms (3)

1

EXPERIMENTAL

CF, Zinc acetate

Drug: Zinc acetate (20mg/d)

2

EXPERIMENTAL

CF, Placebo

Drug: Zinc acetate (20mg/d)

3

NO INTERVENTION

Controls

Interventions

Zinc acetate (20mg/d) DRUG

Randomized to receive either 20mg/d zinc as zinc acetate or an identical placebo

1; 2

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cystic Fibrosis Foundation: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Zinc Acetate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ian J Griffin, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2005
• First Posted: March 2, 2005
• Study Start: May 1, 2004
• Study Completion: September 1, 2007
• Last Updated: July 30, 2015

Record last verified: 2005-03

Locations

US (1)