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| Sponsors and Collaborators: |
University of California, Davis International Centre for Diarrhoeal Disease Research, Bangladesh |
|---|---|
| Information provided by: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00453648 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Vitamin A Deficiency |
Behavioral: Consumption of orange-fleshed sweet potatoes |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | March 2008 |
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:
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 RAE/d, 6 d/wk, for 60 days as either:
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 (n=50); and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period (n=50). 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kazi Jamil, MBBS, PhD | jamil@icddrb.org |
| Bangladesh | |
| International Centre for Diarrhoeal Disease Research, Bangladesh | Recruiting |
| Dhaka, Bangladesh | |
| Principal Investigator: Kazi Jamil, MBBS, PhD | |
| Principal Investigator: | Marjorie J Haskell, PhD | University of California, Davis |
| Principal Investigator: | Kenneth H Brown, MD | University of California, Davis |
| Principal Investigator: | Kazi Jamil, MBBS, PhD | International Centre for Diarrhoeal Disease Research, Bangladesh |
More Information
| Study ID Numbers: | Harvest Plus 8025, Harvest Plus 8027, Harvest Plus 8033 |
| Study First Received: | March 27, 2007 |
| Last Updated: | March 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00453648 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
stable isotopes vitamin A beta-carotene orange-fleshed sweet potatoes iron zinc |
absorption bioavailability vitamin A equivalency Bangladesh women |
|
Retinol Vitamin A Deficiency Night Blindness Beta Carotene Vision Disorders Keratomalacia Avitaminosis Eye Diseases Trace Elements Blindness Malnutrition |
Retinol palmitate Vitamin A Vitamins Zinc Nutrition Disorders Micronutrients Orange Iron Carotenoids Deficiency Diseases |
|
Vitamin A Deficiency Night Blindness Vision Disorders Avitaminosis Eye Diseases Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Malnutrition Vitamin A Vitamins Nutrition Disorders Micronutrients Deficiency Diseases |
