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Impact of Consumption of Orange-Fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age
This study is currently recruiting participants.
Study NCT00453648   Information provided by University of California, Davis
First Received: March 27, 2007   Last Updated: March 28, 2007   History of Changes

March 27, 2007
March 28, 2007
March 2006
 
  • Total body vitamin A pool size
  • Plasma retinol concentration
  • Plasma carotenoid concentrations
Same as current
Complete list of historical versions of study NCT00453648 on ClinicalTrials.gov Archive Site
  • Iron absorption
  • Serum ferritin
  • Hemoglobin concentration
  • Zinc absorption
  • Serum zinc concentration
  • Serum transferrin receptors
Same as current
 
Impact of Consumption of Orange-Fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age
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

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.

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 RAE/d, 6 d/wk, for 60 days as either:

  1. boiled OFSP
  2. fried OFSP
  3. retinyl palmitate, or 0 micrograms RAE/d 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 (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.

 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Vitamin A Deficiency
Behavioral: Consumption of orange-fleshed sweet potatoes
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
March 2008
 

Inclusion Criteria:

  • Serum retinol concentration < 1.12 umol/L
  • Serum C-reactive protein concentration < 10 mg/L

Exclusion Criteria:

  • Pregnant
  • Lactating
  • Diarrhea within past week
  • Severe anemia (< 9g Hb/dL)
  • Symptoms of nightblindness
  • Clinical symptoms of xerophthalmia
  • Chronic disease
Female
18 Years to 45 Years
Yes
Contact: Kazi Jamil, MBBS, PhD jamil@icddrb.org
Bangladesh
 
NCT00453648
 
Harvest Plus 8025, Harvest Plus 8027, Harvest Plus 8033
University of California, Davis
International Centre for Diarrhoeal Disease Research, Bangladesh
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
University of California, Davis
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP