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

May 24, 2017 updated by: University of California, Davis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Other: White-fleshed sweet potatoes
Experimental: 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
Other: Orange-fleshed sweet potatoes (boiled)
Experimental: 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
Other: Orange-fleshed sweet potatoes (fried)
Active Comparator: 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
Other: WFSP and capsule of retinyl palmitate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total body vitamin A pool size
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Iron absorption
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

  • Principal Investigator: Marjorie J Haskell, PhD, University of California, Davis
  • Principal Investigator: Kazi Jamil, MBBS, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimate)

March 29, 2007

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200513770
  • Harvest Plus 8027 (Other Grant/Funding Number: Harvest Plus Program)
  • Harvest Plus 8033 (Other Grant/Funding Number: Harvest Plus Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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