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

Primary Purpose

Vitamin A Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
White-fleshed sweet potatoes
Orange-fleshed sweet potatoes (boiled)
Orange-fleshed sweet potatoes (fried)
WFSP and capsule of retinyl palmitate
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin A Deficiency focused on measuring stable isotopes, vitamin A, beta-carotene, orange-fleshed sweet potatoes, iron, zinc, absorption, bioavailability, vitamin A equivalency, Bangladesh, women

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Active Comparator

    Arm Label

    White-fleshed Sweet Potato

    Orange-fleshed Sweet Potato (boiled)

    Orange-fleshed Sweet Potato (fried)

    White-fleshed Sweet Potato and retinyl palmitate capsule

    Arm 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

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

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

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

    Outcomes

    Primary Outcome Measures

    Total body vitamin A pool size

    Secondary Outcome Measures

    Iron absorption

    Full Information

    First Posted
    March 27, 2007
    Last Updated
    May 24, 2017
    Sponsor
    University of California, Davis
    Collaborators
    International Centre for Diarrhoeal Disease Research, Bangladesh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00453648
    Brief Title
    Impact of Consumption of Orange-fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis
    Collaborators
    International Centre for Diarrhoeal Disease Research, Bangladesh

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin A Deficiency
    Keywords
    stable isotopes, vitamin A, beta-carotene, orange-fleshed sweet potatoes, iron, zinc, absorption, bioavailability, vitamin A equivalency, Bangladesh, women

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    White-fleshed Sweet Potato
    Arm Type
    Placebo Comparator
    Arm 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
    Arm Title
    Orange-fleshed Sweet Potato (boiled)
    Arm Type
    Experimental
    Arm Description
    600 ug RAE/d as boiled orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk
    Arm Title
    Orange-fleshed Sweet Potato (fried)
    Arm Type
    Experimental
    Arm Description
    600 ug RAE/d as fried orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk
    Arm Title
    White-fleshed Sweet Potato and retinyl palmitate capsule
    Arm Type
    Active Comparator
    Arm Description
    0 ug RAE/d as white-fleshed sweet potato and 600 ug retinol/d as retinyl palmitate, 6d/wk for 10 wk
    Intervention Type
    Other
    Intervention Name(s)
    White-fleshed sweet potatoes
    Intervention Type
    Other
    Intervention Name(s)
    Orange-fleshed sweet potatoes (boiled)
    Intervention Type
    Other
    Intervention Name(s)
    Orange-fleshed sweet potatoes (fried)
    Intervention Type
    Other
    Intervention Name(s)
    WFSP and capsule of retinyl palmitate
    Primary Outcome Measure Information:
    Title
    Total body vitamin A pool size
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Iron absorption
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marjorie J Haskell, PhD
    Organizational Affiliation
    University of California, Davis
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kenneth H Brown, MD
    Organizational Affiliation
    University of California, Davis
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kazi Jamil, MBBS, PhD
    Organizational Affiliation
    International Centre for Diarrhoeal Disease Research, Bangladesh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22933750
    Citation
    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.
    Results Reference
    derived

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

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