Status:
COMPLETED
Behavioral & Nutritional Treatment to Help CF Preschoolers Grow
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystic Fibrosis
Pancreatic Cystic Fibrosis
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief Summary
The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition ...
Detailed Description
Evidence-based nutritional interventions that achieve and sustain optimal growth in young children with cystic fibrosis (CF) do not exist, despite an urgent need. Such an intervention could positively...
Eligibility Criteria
Inclusion
- confirmed diagnosis of cystic fibrosis based upon 2 of the following: a. sweat chloride by quantitative pilocarpine electrophoresis ≥60 milliequivalent/Liter (mEq/L), b. two clinical features consistent with CF, or c. genetic testing demonstrating two mutations associated with CF
- confirmation of pancreatic insufficiency based upon fecal elastase of ≤ 100 micrograms per gram of stool (or an undetectable level)
- age at enrollment to the trial of 2.0 years to 6.0 years
- at least 6 months post CF diagnosis
- consuming an unrestricted fat diet
Exclusion
- diagnosis of developmental delay (i.e., autism, cerebral palsy, or mental retardation)
- receiving supplemental enteral nutrition via nasogastric tube, gastrostomy, or total parenteral nutrition
- diagnosed with another disease/condition (e.g., insulin dependent diabetes, congenital heart disease, significant renal disease, history of bowel resection or short bowel syndrome, colonic strictures) known to affect growth
- taking a medication (e.g., insulin, growth hormone, chronic use of systemic steroids) known to affect growth
- screening assessment shows genetic potential for height as acceptable according to the 2001 Consensus Conference guidelines and diet diary indicates daily Dietary Reference Intake (DRI) of energy average of 140% or greater (DRI of 100% will be determined as the estimated energy requirement \[EER\] based upon the child's age, gender, and an active physical activity level
- weight z score (age and gender adjusted) of \> 1.0
- prior participation in the pilot intervention studies conducted by the PI during the prior period of R01 funding or current participation in an intervention trial conducted by the Cystic Fibrosis Therapeutics Development Network.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00241969
Start Date
January 1 2006
End Date
June 1 2015
Last Update
May 22 2018
Active Locations (5)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
4
Rainbows and Babies Children's Hospital
Cleveland, Ohio, United States, 44106