Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00241969
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT00241969
Study Brief:
Protocol Section:
NCT00241969