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

University of California (UC) Davis

Status: Completed

Conditions: Vitamin A Deficiency

Treatments: Other: WFSP and capsule of retinyl palmitate; Other: Orange-fleshed sweet potatoes (fried); Other: White-fleshed sweet potatoes; Other: Orange-fleshed sweet potatoes (boiled)

Study type: Interventional

Funder types: Other

Identifiers

NCT00453648

Harvest Plus 8033 (Other Grant/Funding Number)

200513770

Harvest Plus 8027 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 4 patient groups, including a placebo group

White-fleshed Sweet Potato

Placebo Comparator group

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

Treatment:

Other: White-fleshed sweet potatoes

Orange-fleshed Sweet Potato (boiled)

Experimental group

Description:

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

Treatment:

Other: Orange-fleshed sweet potatoes (boiled)

Orange-fleshed Sweet Potato (fried)

Experimental group

Description:

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

Treatment:

Other: Orange-fleshed sweet potatoes (fried)

White-fleshed Sweet Potato and retinyl palmitate capsule

Active Comparator group

Description:

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

Treatment:

Other: WFSP and capsule of retinyl palmitate