Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453648
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2007-03-27
Brief Title:
Impact of Consumption of Orange-fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Efficacy of Daily Consumption of Sweet Potatoes for Increasing Total Body Vitamin A Pool Size and the Effect of Consumption of Sweet Potatoes on Iron and Zinc Absorption in Bangladeshi Women of Reproductive Age
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The primary purpose of this study is to determine whether daily consumption of orange-fleshed sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in Bangladeshi women of reproductive age
Detailed Description:
Biofortification of plant source foods is a promising strategy for increasing dietary vitamin A intake and vitamin A status in populations at risk of deficiency The primary purposes of this study are
1 to assess the efficacy of daily consumption of boiled or fried orange-fleshed sweet potatoes OFSP for increasing the vitamin A status of non-pregnant non-lactating Bangladeshi women and
2 to estimate the relative vitamin A equivalency of beta-carotene from the two different preparations of OFSP boiled or fried
Secondary purposes are to assess the effect of daily consumption of OFSP on intestinal absorption of iron and zinc Specifically 120 non-pregnant non-lactating women at risk of vitamin A deficiency will be randomly assigned to one of the following 4 treatment groups to receive 600 micrograms RAEd 6 dwk for 60 days as either
1 boiled OFSP
2 fried OFSP
3 retinyl palmitate or 0 micrograms RAEd as white-fleshed sweet potato WFSP
The paired stable isotope dilution technique will be used to estimate total body vitamin A pool size before and after 60-days of supplementation The efficacy of consumption of OFSP will be assessed by comparing the mean change in vitamin A pool size in the OFSP groups to the mean change in vitamin A pool size in the negative control group WFSP group Relative vitamin A equivalency factors will be estimated by comparing the mean change in vitamin A pool size in the OFSP groups with the mean change in vitamin A pool size in the retinyl palmitate group Intestinal iron absorption and iron status will be assessed before and after the 60-day supplementation period in a subset of women n50 and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period n50 Intestinal absorption of iron and zinc will be compared by treatment group to determine whether consumption of OFSP has any effect on iron or zinc absorption in these women
1 to assess the efficacy of daily consumption of boiled or fried orange-fleshed sweet potatoes OFSP for increasing the vitamin A status of non-pregnant non-lactating Bangladeshi women and
2 to estimate the relative vitamin A equivalency of beta-carotene from the two different preparations of OFSP boiled or fried
Secondary purposes are to assess the effect of daily consumption of OFSP on intestinal absorption of iron and zinc Specifically 120 non-pregnant non-lactating women at risk of vitamin A deficiency will be randomly assigned to one of the following 4 treatment groups to receive 600 micrograms RAEd 6 dwk for 60 days as either
1 boiled OFSP
2 fried OFSP
3 retinyl palmitate or 0 micrograms RAEd as white-fleshed sweet potato WFSP
The paired stable isotope dilution technique will be used to estimate total body vitamin A pool size before and after 60-days of supplementation The efficacy of consumption of OFSP will be assessed by comparing the mean change in vitamin A pool size in the OFSP groups to the mean change in vitamin A pool size in the negative control group WFSP group Relative vitamin A equivalency factors will be estimated by comparing the mean change in vitamin A pool size in the OFSP groups with the mean change in vitamin A pool size in the retinyl palmitate group Intestinal iron absorption and iron status will be assessed before and after the 60-day supplementation period in a subset of women n50 and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period n50 Intestinal absorption of iron and zinc will be compared by treatment group to determine whether consumption of OFSP has any effect on iron or zinc absorption in these women
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 |
|---|---|---|---|
| Harvest Plus 8033 | OTHER_GRANT | Harvest Plus Program | None |
| Harvest Plus 8027 | OTHER_GRANT | None | None |