- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680212
Vitamin A Equivalence of Plant Carotenoids in Children
Phase 2 Study of VITAMIN A EQUIVALENCE OF PLANT CAROTENOIDS IN CHILDREN
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- USDA Human Nutrition Research Center on Aging, Tufts Uni.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy children
Exclusion Criteria:
- food allergy
- parasitic infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 1
dietary carotenoids
|
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene 0.5 mg oil capsule
spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene, 0.5 mg oil dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
conversion efficiency of b-C to retinol
Time Frame: up to 21 days
|
up to 21 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Vision Disorders
- Night Blindness
- Vitamin A Deficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Provitamins
- Beta Carotene
- Carotenoids
Other Study ID Numbers
- IRB 8458
- R01DK060021 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin A Deficiency
-
SourseCitruslabsActive, not recruitingMood | Energy Supply; Deficiency | B12 Deficiency VitaminUnited States
-
Boston UniversityCompletedVitamin D Deficiency | Vitamin E Deficiency | Hypovitaminosis AUnited States
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustEnrolling by invitationIron Deficiency (Without Anemia) | B12 Deficiency VitaminUnited Kingdom
-
Kansas State UniversityNational Institute for Medical Research, Tanzania; United States Department... and other collaboratorsCompletedAnemia, Iron-Deficiency | Deficiency, Vitamin A
-
Newcastle UniversityBill and Melinda Gates Foundation; Institute of Nutrition of Central America... and other collaboratorsUnknownVitamin A Deficiency | Vitamin A Toxicity | Hypervitaminosis AGuatemala, United Kingdom
-
Fatih Sultan Mehmet Training and Research HospitalActive, not recruitingVitamin D Deficiency | Lipedema | B12 Deficiency VitaminTurkey
-
Nottingham University Hospitals NHS TrustNorthern Care Alliance NHS Foundation Trust; Barts & The London NHS Trust; University... and other collaboratorsNot yet recruitingParesthesia | Neurologic Symptoms | B12 Deficiency Vitamin | Nitrous Oxide Abuse | Subacute Combined Cord Degeneration
-
University of Wisconsin, MadisonNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedVitamin A Deficiency | Vitamin A ToxicityUnited States
-
University of California, DavisPenn State University; University of Ghana; Newcastle University; Helen Keller...CompletedAnemia | Dietary Habits | Iron Deficiency | Vitamin A Deficiency | Vitamin B 12 Deficiency | Folate Deficiency | Zinc DeficiencyGhana
Clinical Trials on dietary carotenoids
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityBlackmores (China) CO., LtdNot yet recruiting
-
University of UtahAbbottCompletedRetinopathy of PrematurityUnited States
-
Puerta de Hierro University HospitalCompletedPostmenopausal DisorderSpain
-
National Taiwan University HospitalShin Kong Wu Ho-Su Memorial Hospital; Chang Gung Memorial Hospital; Taipei Veterans... and other collaboratorsRecruiting
-
Felipe Medeiros, MDHeidelberg Engineering GmbH; MacuHealth LP; Industrial Orgánica S.A. de C.V.Terminated
-
Tufts UniversityBASFCompleted
-
Yong ZhouSichuan Provincial Science and Technology Support Project (2016SZ0047)CompletedGastrointestinal Tract CancerChina
-
Unilever R&DAspect ClinicalCompletedVascular Diseases | Impaired Glucose ToleranceUnited Kingdom
-
Tufts UniversityCompleted
-
Penn State UniversityOrlando Regional Medical Center; MacuHealthNot yet recruiting