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

Sponsors

Lead Sponsor: University of California, Davis

Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh

Source University of California, Davis
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 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.

Overall Status Completed
Start Date March 2006
Completion Date December 2009
Primary Completion Date December 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Total body vitamin A pool size 3 years
Secondary Outcome
Measure Time Frame
Iron absorption 3 years
Enrollment 130
Condition
Intervention

Intervention Type: Other

Intervention Name: White-fleshed sweet potatoes

Arm Group Label: White-fleshed Sweet Potato

Intervention Type: Other

Intervention Name: Orange-fleshed sweet potatoes (boiled)

Arm Group Label: Orange-fleshed Sweet Potato (boiled)

Intervention Type: Other

Intervention Name: Orange-fleshed sweet potatoes (fried)

Arm Group Label: Orange-fleshed Sweet Potato (fried)

Intervention Type: Other

Intervention Name: WFSP and capsule of retinyl palmitate

Arm Group Label: White-fleshed Sweet Potato and retinyl palmitate capsule

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Verification Date

May 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: White-fleshed Sweet Potato

Type: Placebo Comparator

Description: 0 ug retinol activity equivalents (RAE)/d as boiled white-fleshed sweet potatoes (WFSP) and a corn oil capsule, 6d/wk for 10 wk

Label: Orange-fleshed Sweet Potato (boiled)

Type: Experimental

Description: 600 ug RAE/d as boiled orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk

Label: Orange-fleshed Sweet Potato (fried)

Type: Experimental

Description: 600 ug RAE/d as fried orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk

Label: White-fleshed Sweet Potato and retinyl palmitate capsule

Type: Active Comparator

Description: 0 ug RAE/d as white-fleshed sweet potato and 600 ug retinol/d as retinyl palmitate, 6d/wk for 10 wk

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov