Ileostomy, Colostomy, and Ileoanal Reservoir Surgery |
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Clinical Trial: The STOVITA-Study; Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients
This study has been completed.
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Purpose
| Condition | Intervention |
|---|---|
| Health Ileostomy | Behavior: absorption and conversion of beta-carotene in human GI tract |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-availability Study
Official Title: Bioefficacy and Bioavailability of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients Measuring Using Specifically 13C-Labelled Beta-Carotene and Retinol
Expected Total Enrollment: 18
Study start: July 2004; Study completion: August 2005
Last follow-up: October 2004; Data entry closure: November 2004
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- men and women between 18 and 75 years old
- BMI between 18 and 30 kg/m2
- willing to consume the controlled diet and not consuming other food items
- willing to consume the capsules every day
- having an functional ileostomy (output <2 L/d)
- relative good medical, nutritional and health status
Exclusion Criteria:
- diseases which disturb normal digestion and absorption
- use of (oral) drugs suspected of interfering with fat-soluble vitamin absorption
- excessive alcohol consumption (>30 g/d)
- consumption of vitamin or carotenoid supplements 6 wk before and during the study
- not too low or high serum beta-carotene and retinol
- normal hemoglobin, hemocytometry, creatinine, ALAT, alkalic phosphatase, cholesterol blood values (compared with laboratory references)
- pregnancy
Location Information
Netherlands, Gelderland
Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, 6500HB, Netherlands
Ton HJ Naber, MD PhD, Study Director, Radboud University
Clive E West, PhD DSc, Principal Investigator, Radboud University
Carolien A Bouwman, MSc, Study Chair, Radboud University
More Information
Publications
van Lieshout M, West CE, Muhilal, Permaesih D, Wang Y, Xu X, van Breemen RB, Creemers AF, Verhoeven MA, Lugtenburg J. Bioefficacy of beta-carotene dissolved in oil studied in children in Indonesia. Am J Clin Nutr. 2001 May;73(5):949-58.
van Lieshout M, West CE, van Breemen RB. Isotopic tracer techniques for studying the bioavailability and bioefficacy of dietary carotenoids, particularly beta-carotene, in humans: a review. Am J Clin Nutr. 2003 Jan;77(1):12-28. Review.
Last Updated: August 9, 2005
Record first received: August 9, 2005
ClinicalTrials.gov Identifier: NCT00128804
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23

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