Impact of Consumption of Orange-fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitamin A Deficiency

Intervention / Treatment
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* Other: White-fleshed sweet potatoes
* Other: Orange-fleshed sweet potatoes (boiled)
* Other: Orange-fleshed sweet potatoes (fried)
* Other: WFSP and capsule of retinyl palmitate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: White-fleshed Sweet Potato<br>0 ug retinol activity equivalents (RAE)/d as boiled white-fleshed sweet potatoes (WFSP) and a corn oil capsule, 6d/wk for 10 wk | Other: White-fleshed sweet potatoes<br> <br> |
| Experimental: Orange-fleshed Sweet Potato (boiled)<br>600 ug RAE/d as boiled orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk | Other: Orange-fleshed sweet potatoes (boiled)<br> <br> |
| Experimental: Orange-fleshed Sweet Potato (fried)<br>600 ug RAE/d as fried orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk | Other: Orange-fleshed sweet potatoes (fried)<br> <br> |
| Active Comparator: White-fleshed Sweet Potato and retinyl palmitate capsule<br>0 ug RAE/d as white-fleshed sweet potato and 600 ug retinol/d as retinyl palmitate, 6d/wk for 10 wk | Other: WFSP and capsule of retinyl palmitate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body vitamin A pool size |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron absorption |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stable isotopes, vitamin A, beta-carotene, orange-fleshed sweet potatoes, iron, zinc, absorption, bioavailability, vitamin A equivalency, Bangladesh, women