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| Sponsors and Collaborators: |
Children's Hospital of Philadelphia Solvay Pharmaceuticals |
| Information provided by: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00572975 |
Purpose
*The purpose of this study is to develop a more accurate, reliable, specific and more acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying fat malabsorption in people with CF and pancreatic insufficiency.
| Condition | Intervention | Phase |
|
Cystic Fibrosis Pancreatic Insufficiency |
Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA) |
Phase IV |
| Genetics Home Reference related topics: | cystic fibrosis |
| MedlinePlus related topics: | Cystic Fibrosis |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea |
| Estimated Enrollment: | 9 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | March 2008 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA)
Two fats (Pentadecanoic acid and Triheptadecanoin) are administered in a breakfast shake for the purposes of determining malabsorption. in breakfast shake x1 |
Prior to each study visit all subjects will be required to:
Eligibility
| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ruth M Bradford | 267-426-5747 | bradford@email.chop.edu |
| Contact: Janice L Weber, R.N. | 267-426-7308 | weberj@email.chop.edu |
| United States, Pennsylvania | |||||
| The Children's Hospital of Philadelphia | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19104-4399 | |||||
| Contact: Ruth M Bradford 267-426-5747 bradford@email.chop.edu | |||||
| Contact: Janice L Weber, R.N. 267-426-7308 Weberj@email.chop.edu | |||||
| Principal Investigator: Maria R Mascarenhas, M.D. | |||||
| Children's Hospital of Philadelphia |
| Solvay Pharmaceuticals |
| Principal Investigator: | Maria Mascarenhas, M.D. | Children's Hospital of Philadelphia |
More Information
| Responsible Party: | The Children's Hospital of Philadelphia ( Maria R. Mascarenhas, M.D. ) |
| Study ID Numbers: | 2004-5-3733 |
| First Received: | December 11, 2007 |
| Last Updated: | February 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00572975 |
| Health Authority: | United States: Institutional Review Board |
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