NCT Number: NCT00453648
Impact of Consumption of Orange-fleshed Sweet Potatoes on the Vitamin A Status of 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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
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:
- 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
- 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:
- boiled OFSP
- fried OFSP
- 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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Orange-fleshed sweet potatoes (boiled)
OtherOrange-fleshed sweet potatoes (fried)
OtherWFSP and capsule of retinyl palmitate
OtherPrimary outcomes
-
Total body vitamin A pool size
Time frame: 3 years
Secondary outcomes
-
Iron absorption
Time frame: 3 years
Sponsors and collaborators
Lead sponsor
University of California, Davis
Other
Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
Registry information
Official study 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
Important dates
- Study start
- 2006
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Mar 29, 2007
- Registry last updated
- May 30, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Knowledge of Students About Vitamin A and Assessment of Eye Manifestations in Quranic Schools (Khalwai) Khartoum State, Sudan 2022
NCT06989879
Avitaminosis, Deficiency Diseases
Khartoum, Sudan
View Trial DetailsEffect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
NCT05178407
Anemia, Anemia, Hypochromic
Accra, Ghana
View Trial DetailsImpact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages
NCT05893901
Anemia, Anemia, Hypochromic
Niamey, Niger
View Trial DetailsSenegal Market Study for Food-to-Food Fortified (F2F) Instant Porridge Flours
NCT05872061
Anemia, Anemia, Hypochromic
Dakar, Senegal
View Trial Details