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

NCT ID: NCT00453648

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-12-31

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.

Conditions

Vitamin A Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

White-fleshed Sweet Potato

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

Group Type: PLACEBO_COMPARATOR

White-fleshed sweet potatoes

Intervention Type: OTHER

Orange-fleshed Sweet Potato (boiled)

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

Group Type: EXPERIMENTAL

Orange-fleshed sweet potatoes (boiled)

Intervention Type: OTHER

Orange-fleshed Sweet Potato (fried)

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

Group Type: EXPERIMENTAL

Orange-fleshed sweet potatoes (fried)

Intervention Type: OTHER

White-fleshed Sweet Potato and retinyl palmitate capsule

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

Group Type: ACTIVE_COMPARATOR

WFSP and capsule of retinyl palmitate

Intervention Type: OTHER

Interventions

White-fleshed sweet potatoes

Intervention Type: OTHER

Orange-fleshed sweet potatoes (boiled)

Intervention Type: OTHER

Orange-fleshed sweet potatoes (fried)

Intervention Type: OTHER

WFSP and capsule of retinyl palmitate

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjorie J Haskell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Kenneth H Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Kazi Jamil, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

References

Jamil KM, Brown KH, Jamil M, Peerson JM, Keenan AH, Newman JW, Haskell MJ. Daily consumption of orange-fleshed sweet potato for 60 days increased plasma beta-carotene concentration but did not increase total body vitamin A pool size in Bangladeshi women. J Nutr. 2012 Oct;142(10):1896-902. doi: 10.3945/jn.112.164830. Epub 2012 Aug 29.

Reference Type: DERIVED

PMID: 22933750 (View on PubMed)

Other Identifiers

Harvest Plus 8027

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Harvest Plus 8033

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

200513770

Identifier Type: -

Identifier Source: org_study_id