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| Tracking Information | |||||
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| First Received Date ICMJE | May 16, 2008 | ||||
| Last Updated Date | February 17, 2009 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
conversion efficiency of b-C to retinol [ Time Frame: up to 21 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00680212 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vitamin A Equivalence of Plant Carotenoids in Children | ||||
| Official Title ICMJE | Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN | ||||
| Brief Summary | Our objectives will be to test the following hypotheses and to make the following determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The absorption of provitamin A carotenes and their bioconversion to vitamin A are different in children with or without adequate vitamin A nutrition. (3) To define the vitamin A equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope reference method in children with or without adequate vitamin A nutrition and to compare those values with values derived from model based compartmental analysis. (4) To determine the number and time of blood samples needed for future studies in various field settings on the retinol equivalence of a large number of plant sources. |
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| Detailed Description | This project is to determine the vitamin A value (equivalence) of dietary provitamin A carotenes from spinach, Golden Rice, and pure ß-carotene (ß-C) in oil. These experiments will be conducted in children (ages 6-8) with/without adequate (marginal deficiency) vitamin A nutrition. As plant provitamin A carotenoids are a major and safe vitamin A source for a vast population in the world, it is essential to determine the efficiency of provitamin A carotenoid (mainly ß-C) conversion to vitamin A. By introducing ß-C into rice endosperm, Golden Rice may directly benefit consumers by providing vitamin A nutrition. Our investigation uses hydroponically grown, deca-deuterium labeled spinach and Golden Rice, synthetic ß-C-d10 and a vitamin A isotope reference, C13 labeled retinyl acetate (13C10-RAc), to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo. Seventy-two children each will take two meals, breakfast containing 13C10-RAc dose (0.5mg in 0.2g oil capsule) and lunch containing spinach containing 1 mg ß-C (along with white rice), or Golden Rice containing 0.5mg ß-C (along with light colored vegetables), or ß-C oil capsules containing 0.5 mg ß-C in 0.2g oil (along with white rice and light colored vegetables) on the first day of the study. Blood samples will be collected at 1 3, 7, 14, and 21 days after the study doses. The enrichment of labeled ß-C and labeled retinol in human circulation will be determined using advanced liquid chromatography / mass spectrometry and gas chromatography / mass spectrometry. Through the applications of these novel technologies, we will be able to determine the relative biological activities of endogenous carotenoids; that is, the vitamin A value of spinach, Golden Rice, and ß-C in oil capsules for children with/without vitamin A malnutrition. This study will be of importance in planning vitamin A deficiency prevention strategies and also will provide useful information regarding the potential efficacy of a bioengineered crop to provide vitamin A nutrition. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Basic Science, Randomized, Open Label, Placebo Control, Factorial Assignment, Bio-equivalence Study | ||||
| Condition ICMJE | Vitamin A Deficiency | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | 1
dietary carotenoids
Interventions:
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 72 | ||||
| Completion Date | January 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 8 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00680212 | ||||
| Responsible Party | Guangwen Tang, Tufts University | ||||
| Study ID Numbers ICMJE | IRB 8458, R01DK60021 | ||||
| Study Sponsor ICMJE | Tufts University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Tufts University | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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