Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082420
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2004-05-06
Brief Title:
Retinol Equivalence of Plant Carotenoids in Children
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine vitamin A value of beta-carotene in oil capsule spinach and golden rice
The experiments will be conducted in children ages 7-9 withwithout adequate 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 deca-deuterated retinyl acetate RAc-d10 to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo
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 equivalences 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
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
The experiments will be conducted in children ages 7-9 withwithout adequate 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 deca-deuterated retinyl acetate RAc-d10 to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo
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 equivalences 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
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
Detailed Description:
Seventy-two children each will take two meals lunch and supper containing equal amounts of ß-C in labeled spinach along with white rice or Golden Rice along with light colored vegetables or ß-C oil capsules along with white rice and light colored vegetables every day for 7 days Before the two meals the volunteers will take a breakfast with a RAc-d10 dose as a reference for 7 days 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 withwithout vitamin A malnutrition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DK60021 | None | None | None |